Conferences and Meetings on Regulation in Medicine and Pharmacology

Conference-Service.com offers, as part of our business activities, a directory of upcoming scientific and technical meetings. The calendar is published for the convenience of conference participants and we strive to support conference organisers who need to publish their upcoming events. Although great care is being taken to ensure the correctness of all entries, we cannot accept any liability that may arise from the presence, absence or incorrectness of any particular information on this website. Always check with the meeting organiser before making arrangements to participate in an event!

Meeting organisers can submit meetings free of charge for inclusion into the listing.

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1.
 
6th Annual Global Pharma Regulatory Summit 2017
ID
894215
Dates
26 Apr 2017 - 28 Apr 2017
Location
Mumbai, India
Abstract
Indian generic drugs market has posted an impressive growth pattern over the last few years. Currently, the Indian pharmaceutical market is fully dominated by generic drugs and in the near future, this scenario is likely to remain the same. The Indian pharmaceuticals market increased at a CAGR of 17.46 per cent during 2005-16 with the market increasing from US$ 6 billion in 2005 to US$ 36.7 billion in 2016 and is expected to expand at a CAGR of 15.92 per cent to US$ 55 billion by 2020. But at the same time there are immense of regulatory concerns raised by the global authorities over the the quality of drugs manufactured in India. Keeping this in mind CPhI India brings you the 6th Edition of Global Pharma Regulatory Summit 2017 scheduled on 26-27-28 April in Mumbai, focusing on the clarification and interpretation to the most critical regulatory guidelines faced by the Indian Pharma companies. This three day strategic summit provides insights on the US, Europe and ROW region which are constitute to the major revenue of the top Indian pharmaceutical companies
Contact
Sean Palanna;     Phone: [91 22 61727072];     Email: sean.palanna@ubm.com
Topics
Pharma regulatory
2.
 
Training — Setting up and running Virtual Clinics
ID
870732
Start date
28 Apr 2017
Location
London, United Kingdom
Abstract
Chaired by Mr Bibhas Roy, Consultant Orthopaedic Surgeon and Virtual Orthopaedic Clinic Lead at Central Manchester University Hospitals NHS Foundation Trust, this conference focuses on setting up and running virtual clinics. Expert sessions, case studies and an extended masterclass will focus on understanding service virtualisation, developing virtual clinics, developing policy and procedure to support clinic working and understanding information governance implications. Follow the conference on Twitter #VirtualClinics A 20% discount is available by quoting ref: hcuk20c-s when booking.
Contact
8 Wilson Drive, Ottershaw, Surrey KT16 0NT;     Phone: 0044/1932 429933;     Email: kerry@hc-uk.org.uk
Topics
Virtual Clinic
3.
 
Navigating the Maze for Post-Market Compliance -- Complaint Handling, MDRs, Recalls and Proposed Guidance on FDA Risk Benefits
ID
878104
Dates
04 May 2017 - 05 May 2017
Location
Pittsburgh, United States
Abstract
This interactive one and a half day course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief, who has more than 36 years’ experience with the FDA will provide the participants tools to minimize risk of regulatory enforcement actions. During the seminar, Ms. Hoffman will explain proper handling of complaints reportable or non-reportable, product complaint handling and documentation, how and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall. She will also discuss how to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real life experiences of FDA. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
medical device recalls seminar, medical device regulations seminar, medical device reporting, medical device complaint management, medical device complaint handling
4.
 
Training — Investigation of Deaths in NHS Trusts: Implementing the CQC Recommendations
ID
879500
Start date
08 May 2017
Location
London, United Kingdom
Abstract
The Care Quality Commission released their report and recommendations into learning from deaths while in the NHS on Tuesday 13th December 2016. Chaired by Dr Martin Farrier Clinical Director for Quality & Consultant Paediatrician Wrightington, Wigan and Leigh NHS Foundation Trust, this one day CPD certified conference will demonstrate how to effectively implement the CQC recommendations in practice. The conference will provide an important opportunity for you to share experiences, raise issues and seek clarity through discussion with expert speakers and colleagues working in the same specialism. Follow the conference on Twitter #CQCDeathsreview A 20% discount is available by quoting ref: hcuk20c-s when booking.
Contact
8 Wilson Drive, Ottershaw, Surrey KT16 0NT;     Phone: 0044/1932 429933;     Email: kerry@hc-uk.org.uk
Topics
Mortality, CQC, Serious Incidents
5.
 
Training — Controlled Drugs: Safe Use, Prescribing and Management: Monitoring Adherence to the 2016 NICE Guidance
ID
879649
Start date
11 May 2017
Location
Birmingham, United Kingdom
Abstract
This conference focuses on the safe use, prescribing and management of controlled drugs including monitoring adherence against the 2016 NICE guidance on the safe use and management of controlled drugs. NICE stated that the new guidance will help health and social care professionals negotiate complex legislation and regulations to ensure they are doing all they can to care for patients being treated with controlled drugs. There is also a focus on reporting and investigations of concerns and working in partnership with the police. Follow the conference on Twitter #controlleddrugs A 20% discount is available by quoting ref: hcuk20c-s when booking.
Contact
8 Wilson Drive, Ottershaw, Surrey KT16 0NT;     Phone: 0044/1932 429933;     Email: kerry@hc-uk.org.uk
Topics
Controlled Drugs, Prescribing, Pharmacy
6.
 
PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation
ID
878114
Dates
11 May 2017 - 12 May 2017
Location
San Francisco, United States
Abstract
The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness. It includes audit of the pharmacovigilance system which is covered by the quality system. The GVP Modules are applicable to EU-based companies and any company marketing medicinal products on a global basis. The legally required risk based audit strategy shall cover all PV processes and tasks undertaken by or delegated to other departments, MAH affiliates, and third parties such as distributors, external service providers, partners (the PV Universe). The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
PV Audit Strategy Planning, The European Medicines Agency's (EMA) Guideline, Good Pharmacovigilance Practices (GVP), risk-based audits, GVP Modules, PV Universe
7.
 
Training — In-depth legal masterclass: Informed Consent After Lanarkshire
ID
879658
Start date
12 May 2017
Location
London, United Kingdom
Abstract
This one-day course will cover all elements of informed consent as well as the law relating to treatment of those who lack capacity and who are unable to give informed consent. All delegates will have the opportunity to discuss their own areas of concern with an experienced healthcare lawyer. A 20% discount is available by quoting ref: hcuk20c-s when booking.
Contact
8 Wilson Drive, Ottershaw, Surrey KT16 0NT;     Phone: 0044/1932 429933;     Email: kerry@hc-uk.org.uk
Topics
Informed Consent, Law
8.
 
Training — End of Life Care: Advanced Legal Issues Masterclass
ID
879631
Start date
15 May 2017
Location
London, United Kingdom
Abstract
This one-day interactive masterclass will provide healthcare practitioners involved in palliative and elderly care an in-depth knowledge of the legal framework for end of life care. To enable delegates to maximise the benefit from this masterclass, they will need a good understanding of mental capacity, the Mental Health Act, common law framework and best interests. They must also understand the DoLS assessments and process. A 20% discount is available by quoting ref: hcuk20c-s when booking.
Contact
8 Wilson Drive, Ottershaw, Surrey KT16 0NT;     Phone: 0044/1932 429933;     Email: kerry@hc-uk.org.uk
Topics
Palliative, Legal, End of Life Care
9.
 
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
ID
878102
Dates
15 May 2017 - 16 May 2017
Location
Boston, United States
Abstract
The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs). These guidances align Process Validation activities with a product lifecycle concept and with existing FDA and EU guidances, including the FDA/International Conference on Harmonization (ICH), Guidance for Industry, Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. The lifecycle concept, new to these Guidances, link product and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production. These guidances also support process improvement and innovation through sound science and risk management. The new Process Validation Guideline/Practice incorporate elements of Process Validation as early as the Research and Development phase, and continues onward through Technology Transfer, into the Phase 1 IND Clinical Trial manufacturing phase, and ultimately into Phase 2 and 3, and then commercial manufacturing. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA Process Validation Guidance, EU Annex 15, Active Pharmaceutical Ingredients (APIs), International Conference on Harmonization (ICH)
10.
 
Manufacturing and Marketing OTC Drugs in Compliance with FDA Regulations (Updated to address recent Homeopathic Drug announcements by FDA & FTC)
ID
878123
Dates
16 May 2017 - 17 May 2017
Location
Philadelphia, United States
Abstract
This interactive one-and-a-half-day seminar is intended to educate regulatory and quality professionals regarding the rather complicated regulations that distinguish Non-prescription Drugs from other products such as foods, cosmetics, dietary supplements and prescription drugs that sometimes contain the same ingredients. Recent FDA actions such as the banning of antibacterial soaps and ongoing programs that may impact manufacturers and private label distributors will be discussed. It will explain differences in the way homeopathic and conventional drugs are regulated and update participants on FDA’s application of GMP regulations to manufacturing low risk drugs that could be sold as cosmetics with the same ingredients, but different labeling. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Cosmeceuticals, dietary supplements, cosmetics, homeopathic OTCs, FDA regulations, FDA GMPS, good manufacturing practices, over the counter, low risk OTC drugs, warning letters, FDA enforcements actions, FDA marketing regulations
11.
 
GMP Compliance for Quality Control and Contract Laboratories
ID
878177
Dates
16 May 2017 - 17 May 2017
Location
Sydney, United States
Abstract
This program will cover the requirements for laboratory controls under US GMP regulations and compare them to those applied by other international health regulatory authorities. Laboratory controls relating to equipment calibration and preventive maintenance; sample chain of custody; good documentation practices; investigation of out of specification and out of trend results; analytical method validation; change control; impact of staffing levels and work flow patterns in the lab on GMP compliance; training and other issues will be included under laboratory controls. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Quality Control Lab regulations, contract laboratories, US GMP regulations, analytical method validation, change control, data integrity, laboratory inspection
12.
 
Exploring Data Integrity To Include FDA, WHO and EMA's Latest Guidance for Industry (2015/2016)
ID
878187
Dates
18 May 2017 - 19 May 2017
Location
Boston, United States
Abstract
Data Integrity has become a non-compliance area often observed by the FDA and reported within Form FDA 483s and Warning Letters. While various governments have observed this on a world-wide basis, the FDA has been reporting its occurrence off-shore with a greater frequency than usually observed within the United States. A lack of Data Integrity hints of a Company being outside of compliance and questions the quality of the product being produced. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Data Integrity program, cGMP compliance, regulatory requirements FDA, WHO, EMA, Data integrity workshop, data integrity issues
13.
 
FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials
ID
878142
Dates
18 May 2017 - 19 May 2017
Location
Tampa, United States
Abstract
Because a phase 1 clinical trial initially introduces an investigational new drug into human subjects, appropriate CGMP help ensure subject safety. It is important to implement quality control (QC) principles to the manufacture of phase 1 investigational drugs (i.e., interpreting and implementing CGMP consistent with good scientific methodology), which foster CGMP activities that are more appropriate for phase 1 clinical trials, improve the quality of phase 1 investigational drugs, and facilitate the initiation of investigational clinical trials in humans while continuing to protect trial subjects. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA GMP workshop, FDA GMP Expectations, Phase I, First-in-Man Clinical Trials, CMC Requirements, IND Study, Raw Material Management
Related subject(s)
14.
 
Quality Control Laboratory Compliance - cGMPs and GLPs
ID
878141
Dates
18 May 2017 - 19 May 2017
Location
Philadelphia, United States
Abstract
FDA inspection and oversight of quality control (QC) laboratories are essential elements of the agency’s evaluation of the compliance status of regulated companies representing multiple industries - pharmaceuticals, biologics, medical devices, as well as foods and cosmetics - as well as the contract QC laboratories which service these industries. Lack of compliance can result in severe regulatory actions, criminal liability, fines, and the inability to obtain product approvals. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Quality Control Lab regulations, QC Lab regulations, FDA QC Lab requirements, FDA lab regulations, Good Laboratory Practices, GLP, cGMP, Current Good Manufacturing Practices
15.
 
Product Information for Medicinal Products in the EU
ID
878217
Dates
18 May 2017 - 19 May 2017
Location
Vienna, United States
Abstract
SmPCs are the basis for the preparation of package leaflets, so are important documents in enabling information on medicines to reach patients. By attending this training you will learn documentation, regulation and regulatory affair aspects of medicinal product labelling and packaging in the EU. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
EU medicinal product information guidance, SmPC labelling text, package leaflet, SmPC marketing authorisation, medicine safety requirements in EU, pharmacovigilance (PV) document, EMA/CHMP guidance documents
16.
 
Data Integrity: FDA/EMA/TGA Requirements and Implementation
ID
883758
Dates
18 May 2017 - 19 May 2017
Location
Sydney, United States
Abstract
The integrity of data generated in support of marketing authorizations and in GMP, GCP and GLP regulated activities is foundational to sound decision making and regulatory compliance. Data integrity lapses are among the most serious concerns that pharmaceutical regulatory authorities have. Enforcement penalties can be severe from a business standpoint, and in extreme cases can even impact individuals who are held responsible for the occurrence of data integrity problems. In recent months the topic of data integrity has been in the forefront of concern among worldwide pharmaceutical regulatory agencies. The FDA, EMA, TGA and others have published guidelines setting forth their requirements and expectations for the maintenance of data integrity, as has at least one leading industry organization (PDA).
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
pharma data integrity, GMP, GCP, GLP, FDA, EMA, TGA regulations, data acquisition, ALCOA, Generic Drug Scandal, GXP operations
17.
 
Latin America: Regulatory Compliance Requirements for Life Science Products (Focus: Brazil, Mexico, Argentina)
ID
883691
Dates
18 May 2017 - 19 May 2017
Location
New Orleans, United States
Abstract
This two-day comprehensive Course on Latin America Regulatory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration, amendments and renewals across Pharmaceuticals, Biologics, Medical Devices and Combination Products. The Course will address the structure of the regulatory agencies in Latin America and discuss local cultural nuances to help you be successful in working with the regulators.Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Latin America regulations, Latin America life sciences regulations, Latam life sciences regulatory requirements, Latin America pharmaceutical regulations, Latin America medical device regulations, Latin America biologics regulations
18.
 
Training — Legal Masterclass: Information Sharing for Mental Health Professionals
ID
879747
Start date
19 May 2017
Location
London, United Kingdom
Abstract
This one-day training will provide a practical guide to the legal framework that governs information sharing relevant to those working in Mental Health settings. All principles will be tested via case studies. Delegates will have the opportunity to discuss individual concerns. The trainer will be a practising healthcare lawyer. A 20% discount is available by quoting ref: hcuk20c-s when booking.
Contact
8 Wilson Drive, Ottershaw, Surrey KT16 0NT;     Phone: 0044/1932 429933;     Email: kerry@hc-uk.org.uk
Topics
Information Sharing, Mental Health, Psychiatry
19.
 
Biologistics World Korea 2017
ID
827131
Dates
23 May 2017 - 24 May 2017
Location
Seoul, South Korea
Abstract
Biologistics World Korea is the MOST Targeted event in Korea that focuses on supply chain management and logistics for biologics and vaccines. Located in Singapore, the prime logistics hub of Korea, the programme promises to bring together key opinion leaders, rising players and market experts to discuss, debate and brainstorm on the most pertinent issues affecting Korea’s logistics network within a global context!
Contact
Andrew Darwitan;     Phone: [+65 3109 0156];     Email: andrew.darwitan@imapac.com
20.
 
Auditing for Medical Device and Pharma Companies – A Tool to Reduce Quality and Compliance Risk
ID
883803
Dates
25 May 2017 - 26 May 2017
Location
Boston, United States
Abstract
This 2-day seminar is an essential guide on how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk. However, many companies conduct audits only because they are required to by regulation. Businesses often see internal audit as a non-value added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having an internal audit program, management is often surprised when they receive a 483, Warning Letter, or even a Consent Decree. A well-planned audit program can reduce these risks. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Pharma and medical device internal auditing, internal audit program, FDA's expectations, documentation, risk analysis techniques, audit program structure
21.
 
The Veterinary Drug Approval Process and FDA Regulatory Oversight
ID
883857
Dates
01 Jun 2017 - 02 Jun 2017
Location
Kansas City, United States
Abstract
The U.S. Food and Drug Administration’s Center for Veterinary Medicine or CVM is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. However, FDA does not regulate all products intended for animal use. Jurisdiction over animal products including licensed biologics such as vaccines is shared with a number of other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service or APHIS; and products such as flea and tick collars are regulated by the Environmental Protection Agency. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA veterinary drug approval process, center for veterinary medicine, new animal drug application, investigational new animal drug (INAD) file, animal disease diagnostic devices, veterinary medicine regulations, veterinary drug user fees, Agriculture’s Animal and Plant Health Inspection Service
22.
 
Pre-Filled Syringes West Coast
ID
877327
Dates
05 Jun 2017 - 06 Jun 2017
Location
San Diego, United States
Abstract
SMi Group are thrilled to announce the return of Pre-Filled Syringes West Coast 2017 which arrives to California on June 5th & 6th.

Following on from sell-out shows in Europe and Boston, Pre-Filled Syringes West Coast will once again gather a global audience of medical device experts and PFS industry leaders to discuss new developments and showcase cutting edge advances, keeping you at the forefront of a booming industry. The competitive PFS market has sparked great improvements as devices strive for higher quality, safety, and patient satisfaction. Innovation and excellence is requested at every level making Pre-Filled Syringes West Coast the perfect platform to strengthen knowledge in key principles such as human factor engineering, manufacturing and complex biologics, whilst honing in on emerging trends for parenteral devices, including auto injectors, pens, pumps and smart devices. We will also be welcoming expertise from the likes of Nemera, Nipro PharmaPackaging, Terumo, Worrell, Zeon, Allergan, MedImmune, Xeris Pharmaceuticals, Amgen, Eli Lilly, Genentech, Ferring, Roche and more.

Contact
Teri Arri;     Phone: [+44 (0)20 7827 6000];     Email: tarri@smi-online.co.uk
Topics
prefilled syringe, pre-filled syringe, autoinjector, human factors, device development, innovation, strategy, extractables, leachables, patient safety, compliance, biosimilar, parenteral, packaging, combination products, lyophilisation, freeze drying, injectable, injectable devices, syringe, extractables and leachables, E&L, PFS, drug device, drug delivery, combination products, sterilization, needle, component, glass syringe, cop syringe, container, formulation, device development, human factors, manufacturing, device technology, medical device, parenteral drug, plastic, qbd, drug delivery, infusion, vial, cop, sterilization, clogging
23.
 
Applying the FDA Food Safety Modernization Act (FSMA) to Your Organization
ID
883889
Dates
08 Jun 2017 - 09 Jun 2017
Location
Minneapolis, United States
Abstract
The Food Safety Modernization Act has introduced some of the most sweeping reforms to U.S. food safety laws in more than 70 years. It is mandated that all FDA regulated manufacturers in the United States and any foreign entity who produces food to be consumed within the US must comply to applicable final rules. This seminar offers a 360 degree view of food safety practices from a FSMA-centered approach. The courses will highlight the basics of food safety with an emphasis on compliance. The seminar will provide the tools needed to align your company’s governance, risk management, and compliance programs with new FDA regulations. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FSMA, food safety modernization act, FSMA requirements, food-borne illness, HACCP, food safety, Hazard Analysis and Critical Control Points, FDA food compliance
24.
 
3rd Annual ComplianceOnline Medical Device Summit 2017
ID
884994
Dates
08 Jun 2017 - 09 Jun 2017
Location
Boston, United States
Abstract
Innovate novel ideas for advancements in medical device technologies without compromising their safety and effectiveness. This summit brings together some of the renowned R&D experts and technology innovators to share information regarding opportunities, obstacles, best practices and challenges in the development of the new devices. Attendees will get insight into device innovation trends and upcoming changes in the medical device regulations.

Plan for successfully executing regulatory inspections by providing industry best practices. Panel discussions led by the former FDA office bearers and industry experts will provide a set of comprehensive strategies on how to prepare for and manage an FDA inspection, including how to follow-up and closing out 483s or Warning Letters. Attending this summit will enable you to improve and better prepare for your next inspections.

Build FDA compliant quality management systems. Attend this summit to learn how to develop and implement effective, consistent and reliable quality management systems. Ex-FDA officials and senior company executives will share thoughts and ideas to improve the performance of your current system.

Interact with leading minds in the industry. Attendees will get to network with the prominent decision makers in the industry to exchange ideas, offer thoughts and know-how, and share experiences. Joining this summit will offer a unique opportunity to the attendees to market their offerings and identify new business opportunities.

Deliberate the current state of medical device laws and technology and government oversight. Panel comprising of some of leading medical device experts and veterans will discuss the recent changes to the regulatory environment for the medical device industry and how these changes will impact the approval of new devices. Attendees will gain insight into the current issues and future challenges in the industry. Join this summit to hear from the experts who have extensive experience in all aspects of medical device including R&D, manufacturing quality assurance, approval and commercialization process.

Scale factors for successful medical device commercialization. Discussions with industry veterans through real case studies will help medical researchers, healthcare professionals, industrialists and entrepreneurs better understand the criterias for successful commercialization of medical devices. This summit also offers numerous opportunities for medical device companies and suppliers to showcase their products and services to potential customers, generating leads and growing their businesses.

Enhance risk management strategies for the safe, effective and efficient use of medical devices. Medical device professionals will join together to share their knowledge and best practices for implementing good risk management principles within the industry. Attending this summit will help you to develop a robust and integrated risk management plan to improve quality management system.

Note: Use coupon code NB5SQH8N and get 10% off on registration.

Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Medical Device Summit, Medical Device Seminar, Medical Device Summit 2016, Medical Device Seminars 2016, Medical Device Conferences, Medical Device Events
25.
 
In Vitro Diagnostics
ID
882707
Dates
14 Jun 2017 - 15 Jun 2017
Location
London, United Kingdom
Abstract
The third in its series, SMi is delighted to announce the return of In Vitro Diagnostics taking place in London on the 14th & 15th June 2017. Aimed at Managers/Heads and Directors of Regulatory Affairs, In Vitro Diagnostics, Clinical Affairs and Quality Assurance, IVDs 2017 will provide regulatory updates and key industry feedback from leading IVD manufacturers within this complex and ever-changing landscape. Through a series of presentations from handpicked industry experts and Notified Bodies, the 2017 event will prepare attendees for the challenging times ahead and how to comply with regulatory requirements to ensure direct access to market ensuring the continued growing demand for use and innovation of IVDs over the next decade and beyond. Topics of discussion include: Latest updates on the IVD regulation, the changing role of notified bodies as well as the increase in requirements for clinical evidence.
Contact
Zoe Gale;     Phone: [02078276132];     Email: zgale@smi-online.co.uk
Topics
in vitro, invitro, diagnostics, IVD, medical device, regulation, Notified Bodies, NB, IVDR
26.
 
The A to Z's of Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals, Biologics, Medical Devices, Cosmetics, and Personal Care Products
ID
883888
Dates
15 Jun 2017 - 16 Jun 2017
Location
Newark, United States
Abstract
All facilities manufacturing pharmaceuticals, biologics, medical devices, cosmetics, and personal care products are likely to have high purity water systems. In spite of this purity, microorganisms can flourish within these systems and lead to undesirable contamination of facility processes and their products. Of all the individuals at the facility, it is site’s microbiologists who should understand the microorganisms in water systems and how best to monitor and control them. Sadly, this is often not the case due to the lack of familiarity with biofilm and its impact on water system sampling, testing, sanitization, and routine maintenance. This lack of understanding of microbial control often leads to poor system designs, poor system sampling, poor system maintenance and poor sanitization practices, and as a result, ongoing microbial problems with the water. This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement, since this training is for everyone involved with water systems, from the lab to utility room operations. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential for the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system control and monitoring consists of a set of rules that often don’t work or result in erroneous monitoring data and can cause everything from very costly and unnecessary system downtime to patient injury and product recalls. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Pharmaceutical water systems seminar, water system compliance seminar, water system microbial control, water system microbial monitoring, water system validation
27.
 
SOPs for FDA-Regulated Industry: Best Practices to Withstand FDA Expectations
ID
883876
Dates
15 Jun 2017 - 16 Jun 2017
Location
Boston, United States
Abstract
One of the best ways to ensure that an organization meets its regulatory obligations is to follow SOPs. SOPs are standardized procedures and processes prepared with enough detail to ensure that tasks are performed consistently each time they are done. SOPs are also required to be in compliance with regulations and guidelines internationally, across all regulated functions. Lack of SOPs and not following SOPs are often cited in regulatory inspections as deficiencies that must be corrected. Poorly prepared SOPs or poor compliance with existing SOPs can compromise a drug development program, an effective quality system, and may result in product recalls. This workshop will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within the SOPs. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA SOP requirements, FDA SOPs, FDA regulated industry SOP types, FDA SOP components, SOP training, SOP implementation, SOP template, SOP numbering system
28.
 
Designing and Sustaining New and Existing Product Stability Testing Program
ID
883897
Dates
15 Jun 2017 - 16 Jun 2017
Location
Orlando, United States
Abstract
New or existing modified drug Stability Testing Program's regulations/requirements stipulated by the FDA, 21 CFR or other regulations may sometimes creating an overwhelming situation based on the type of product that is being manufactured. Hence, some manufacturers of new drug products have made inadvertent mistakes in the design of their new drug stability testing program. Such mistakes may ultimately delay the new, existing or modified product IND or NDA application process due to the data that was presented to the FDA (i.e. Relevant aspects of the stability testing program requirement may have been omitted by the drug manufacturers). It is better to understand, follow and apply the full requirements of a new product stability testing requirement from the onset or to correct an existing stability testing program so as to avoid future pitfalls and delayed IND or NDA submission process by the FDA. Having produced a new or existing product, knowing the appropriate way to design and perform the stability testing of the new product which is a prerequisite for setting the product's expiration date and possible extension of the expiration date is critical. Some drug product manufacturers have made mistakes in the past whereby a new product that was manufactured appropriately did not have a good stability testing plan or program hence it delayed the product's ability to have an approved IND or NDA submission. A mistake of this sort has also been made by drug manufactures that resulted in a 483 or Warning letter by the FDA. Knowing how to approach the design of a new product stability program at the onset of the new product design or during an existing product testing is important and will save a company time and cost in moving the product to the next phase. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA's Drug Stability Testing Program, NDA submission, 21CFR 514.1(b)(5)(x) expectations, Analytical Testing Considerations, Laboratory Information Management Systems (LIMS)
29.
 
Bioanalytical Methods and Good Laboratory Practices (GLP) - Essential Elements for Pre-Clinical Studies during development of Drugs
ID
883885
Dates
15 Jun 2017 - 16 Jun 2017
Location
San Francisco, United States
Abstract
Pre-clinical or non-clinical studies are required during drug development to evaluate safety in animals (toxicology) and pharmacokinetics and bioavailability (pharmacology) of drugs prior to initiating the clinical development of a drug. These studies must be performed following the Good Laboratory Practices (GLP) regulations, specified by the US FDA or principles and guidelines developed by the Organisation of Economic Co-operation and Development (OECD). Regulations for the GLP, specified in 21 CFR 58, related guidelines, including “questions and answers” documents, a training handbook and training manuals developed by the World Health Organization (WHO) are available to clarify the regulatory expectations with a view to assisting the sponsors of drugs and contract testing laboratories performing toxicology and pharmacology studies in complying with these regulations. Despite these guidance documents and training materials, GLP regulations are one of the most commonly misunderstood regulations for drug development and manufacturing operations with a number of myths about GLPs. This course will explain various elements of GLPs in detail with a view to comply with the regulations and Law as per regulatory requirements and expectations. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Drugs development requirement, bioanalytical methods, good laboratory practices, GLP, GMP, 21 CFR 58, GLP regulations, pharmacokinetics, bioavailability
30.
 
FDA Requirements for the Pharmaceutical Industry: Inspection, OTC Drugs, IND/NDA/ANDA, eCTD and GMP Requirements
ID
883884
Dates
15 Jun 2017 - 16 Jun 2017
Location
New Jersey, United States
Abstract
This course is intended for employees who need a basic understanding of the FDA rules and regulations for pharmaceuticals. It will cover the basics of various ways to bring a product to market as well as Current Good Manufacturing Practice (cGMP). Items to be discussed include Over-the-Counter (OTC) Monographs, New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), product development overview, Investigational New Drugs (INDs), concepts in clinical trials and bioequivalence trials, amendments and supplements to applications, analytical method and process validation, cGMPs and FDA Inspections. The course is not intended to prepare a student to create any of the matters discussed. Rather it is intended to give the student enough knowledge so that he or she can intelligently participate in discussions of strategy and assignment of resources. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA requirements for the pharmaceutical industry, FDA pharma compliance, current good manufacturing practice (cGMP), over-the-counter (OTC) monographs
31.
 
HIPAA Privacy Rule Compliance-Understanding New Rules and Responsibilities of Privacy Officer
ID
883894
Dates
15 Jun 2017 - 16 Jun 2017
Location
San Francisco, United States
Abstract
With the recent implementation of new HIPAA regulations in the HIPAA Omnibus Update of 2013, healthcare organizations are reviewing their compliance and making sure they have the proper policies, procedures, and forms in place. HIPAA Privacy Officers have been renewing their compliance activities and reviewing their documentation to make sure they can meet the challenges of the new rules and avoid breaches and penalties for compliance violations. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
HIPAA privacy rule, HIPAA regulations, HIPAA compliance
32.
 
Effectively Addressing and Remediating FDA's Form 483 Findings, Warning Letters and Consent Decree Compliance Issues
ID
883860
Dates
19 Jun 2017 - 20 Jun 2017
Location
Orlando, United States
Abstract
This seminar will guide the attendee in effectively handling, addressing and remediating FDA's and other related compliance issues associated such as FDA's Form 483, Warning Letter and Consent Decree Compliance Findings. An effective handling and resolution of Compliance issues will prevent further disciplinary actions such as an FDA's Warning Letter or a formal Consent Decree which ends with a costly impact, fines and possible injunctions by the FDA. Because the impact of non-compliance and remediation of compliance issues are very costly, time consuming and impacting to a business and associated manufactured product including an increasing severity of disciplinary action by the FDA, understanding the triggers, effective preventative and corrective actions and an effective and expedient resolution of such compliance issues will assist a manufacturer of product in preventing expensive remediation of compliance issues, delays to product launch, impact on current commercially available product, overall business reputation, product recall, Fines, loss of impacted Product, loss of business licensure and/or prosecution by the FDA. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA Form 483 Warning Letters, FDA Consent Decree, FDA injunction, Code of Federal Regulations, FDA Form 483 Seminar
33.
 
FDA's New Import Program for 2017 - Strict Precision
ID
884982
Dates
22 Jun 2017 - 23 Jun 2017
Location
San Francisco, United States
Abstract
The FDA continues to change its import program to better manage new problems and to use new procedures to make the whole process easier. The FDA and U.S. Customs and Border Protection (CBP) are relying more and more on computer programs to expedite the import process. When and how you use these programs can make a big difference in the net profit derived from even a single shipment. The new Voluntary Qualified Importer Program (VQIP) is one such example. Another example is CBP’s and FDA’s implementation of the Automated Commercial Environment (ACE) program became mandatory for importers in 2016. If you fail to correctly use new import procedures and programs, you will be operating under an expensive disadvantage. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA import regulations, FDA’s import legal requirements, U.S. Customs and Border Protection, CBP requirements, FDA warning letter, FDA import program, risk of detention
34.
 
How to do Research on Therapeutic Interventions: Protocol Preparation
ID
828732
Dates
03 Jul 2017 - 07 Jul 2017
Location
Oxford, United Kingdom
Abstract
The How to do Research on Therapeutic Interventions: Protocol Preparation course is a one-week module of the MSc in Experimental Therapeutics. Offered by the Department of Oncology and the Department for Continuing Education’s CPD Centre, the teaching will be led by Dr Grant D Vallance, Information Manager at the Oxford University Hospitals NHS Trust, and will feature face-to-face lectures and tutorials from some of Oxford's leading clinicians and scientists.
Contact
Course Administrator;     Phone: [+44(0)1865 286955];     Email: expther@conted.ox.ac.uk
35.
 
Statistical Analysis for Product Development
ID
885014
Dates
12 Jul 2017 - 13 Jul 2017
Location
San Francisco, United States
Abstract
This course is designed to help scientists and engineers understand the statistical methods used in process and product development. Variability is part of every process, design of experiments helps to separate systematic variability from special cause variability. You will get a chance to examine the different sources of variability how it relates to analytical method development, process improvement and sample size selection. The concept of experimental budget will be introduced to help you plan the total number of experiments needed. You will also learn to improve process output characteristics including quality, cost, and robustness through generating empirical models of your processes in the fewest experiments possible. This highly interactive course will allow participants the opportunity to develop strategies for analysis of experimental data. The objective is to provide participants with key technical information along with perspectives to enable them to apply the technologies to their own projects and evolve their own statistical methods to support the various stages of product development. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Statistical Analysis, product development, statistical methods, variability, design of experiments, systematic variability, special cause variability, analytical method development, process improvement, experimental budget
36.
 
Compliance Risk Management in Medical Devices, Pharmaceuticals, and Combination Products
ID
878116
Dates
13 Jul 2017 - 14 Jul 2017
Location
Minneapolis, United States
Abstract
Effective risk management is the hallmark of a successful corporation. Increasingly, it is also the hallmark of a compliant corporation. While Medical Devices, Pharmaceuticals, and Combination Products have had unique histories for the evolution of risk management, the management of compliance risk is a common business process for all three areas. Enterprise Risk Management (ERM) is the generic term for managing the risks of an organization. ISO 31000 is the ERM ISO Standard. This standard provides guidance for organizations on implementing ERM solutions. ISO 9001 is the Quality Systeme Standard. ISO 9001 now requires to establish “risk-based thinking.” As a result, ISO 13485, the International Quality System Standard for Medical Devices, has been revised to include requirements for firms to implement Compliance Risk Management. These requirements are in addition to the requirements as currently defined by ISO 14971, the International Standard for Risk Management of Medical Devices.Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Enterprise Risk Management (ERM) Training, ISO 31000, ERM solutions, ISO 14971 Training, medical device risk management training, Compliance Risk Management
Related subject(s)
37.
 
Understanding the FDA's Regulation of HCT/Ps and Successful Product Development Strategies
ID
885035
Dates
13 Jul 2017 - 14 Jul 2017
Location
Irvine, United States
Abstract
In 1997, the FDA proposed a comprehensive regulatory program for Human Cells, Tissues and Cellular- and Tissue-Based Products (HCT/Ps) outlining the registration and listing procedures for HCT/Ps. This program also differentiates between HCT/Ps that will be regulated via the traditional pathway and those that will undergo approval as new drugs, biologics or devices. In this seminar, we'll discuss the historical context for the use of HCT/Ps in medicine as well as how the HCT/P market is evolving. You will be shown examples of the FDA-approved use of HCT/Ps and what is required for successful product development. This course will also provide an overview of the health authority regulating HCT/Ps, discuss the regulations that govern HCT/Ps, discuss potential product development strategies and provide an overview of product development in the United States. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA regulatory oversight of HCT/Ps, tissue reference group, approval process, good tissue practice, good manufacturing practice, quality system regulations, good laboratory practice, FDA enforcement actions, adverse event reporting, homologous use, adipose tissue, translation medicine
38.
 
Compliance Risk Management in Medical Devices, Pharmaceuticals, and Combination Products
ID
885023
Dates
13 Jul 2017 - 14 Jul 2017
Location
Minneapolis, United States
Abstract
Effective risk management is the hallmark of a successful corporation. Increasingly, it is also the hallmark of a compliant corporation. While Medical Devices, Pharmaceuticals, and Combination Products have had unique histories for the evolution of risk management, the management of compliance risk is a common business process for all three areas. Enterprise Risk Management (ERM) is the generic term for managing the risks of an organization. ISO 31000 is the ERM ISO Standard. This standard provides guidance for organizations on implementing ERM solutions. ISO 9001 is the Quality Systeme Standard. ISO 9001 now requires to establish “risk-based thinking.” As a result, ISO 13485, the International Quality System Standard for Medical Devices, has been revised to include requirements for firms to implement Compliance Risk Management. These requirements are in addition to the requirements as currently defined by ISO 14971, the International Standard for Risk Management of Medical Devices. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Enterprise Risk Management (ERM) Training, ISO 31000, ERM solutions, ISO 14971 Training, medical device risk management training, Compliance Risk Management
39.
 
FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies
ID
885088
Dates
13 Jul 2017 - 14 Jul 2017
Location
Irvine, United States
Abstract
Stem cells harness the power to differentiate into numerous cells upon stimulation. This has led to their wide exploration across all of medicine, including high risk diseases. Of course, significant scientific breakthroughs in the use of stem cells to prevent, diagnose, and treat numerous diseases has caused numerous start-up companies to form. Despite, such promise, the FDA has yet to approve stem cell therapies for a wide range of diseases, except cord blood-derived hematopoietic progenitor cells for certain indications. This tutorial will provide an historical context for the use of stem cells in medicine, where the field has been and where it is going. It will also provide the few examples of FDA approved use of stem cells in medicine and what is needed for the field to progress. For example, in 2006, the U.S. FDA implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products. Currently, there is an ongoing debate in industry on how such therapies should be regulated, in particular by the FDA or under the practice of medicine, under federal law or state law, and as drugs or simply biologics. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Regenerative medicine regulations, Stem Cell Treatments, biomaterials, FDA regulates regenerative treatments and therapies, good manufacturing, good laboratory practices
40.
 
A Comprehensive View of FDA Regulations for Medical Devices
ID
885043
Dates
20 Jul 2017 - 21 Jul 2017
Location
Cambridge, United States
Abstract
Don’t let a common misunderstanding get you into trouble! There is more to the US Medical Device Regulations than Part 820. Companies that don’t understand will face regulatory scrutiny and receive FDA Form 483s and Warning Letters. Recently a device manufacturer got a Warning Letter relating to updates to shipped devices, which said, “The Quality Manager stated he was unaware of the corrections and removal reporting and recordkeeping requirements.” Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
US medical device regulations, FDA medical device compliance best practices, FDA QSR, medical device reports (MDR), Unique Device Identification (UDI), Quality System Inspection Technique (QSIT), FDA inspections, medical device manufacturer
41.
 
FDA Recalls - Before You Start, and After You Finish
ID
885064
Dates
03 Aug 2017 - 04 Aug 2017
Location
Salt Lake City, United States
Abstract
FDA's recall authority and program launches you into a project of crisis management. You will learn how to establish a roadmap for conducting recalls. The knowledge you gain will sharpen your recall management decisions and strategy. You will learn how to use the FDA's health risk criteria so you can develop effective recall procedures. One critical aspect of recalls involves the identification of the root cause of the recall and how you could or should prevent that problem from happening again. Your corrective and preventive action program (CAPA) and quality assurance functions require a rigorous approach to prevent a chronic history of recalls. Reiterative recalls lead the FDA to the conclusion that,
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA Recall, FDA recall classes, FDA recall guidance, FDA recall procedures, regulatory management, CAPA, FDA inspection, Recall Regulations, Mandatory recall actions
42.
 
Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)
ID
885052
Dates
12 Sep 2017 - 13 Sep 2017
Location
Boston, United States
Abstract
Analytical methods and procedures should be validated to ensure reliability, consistency and accuracy of analytical data. Compendial methods should be verified to demonstrate the suitability of laboratories to successfully run the method and when methods are transferred between laboratories successful transfer should be demonstrated through testing. In case a laboratory wants to use an alternative method instead of a compendial method, equivalency of the alternative method to the compendial method should be demonstrated. Method validation recently got highest attention from regulatory agencies and industry task forces. For example, FDA and EMA released guidelines on method validation and transfer, and USP has proposed new approaches chapters for integrated validation, verification and transfer of analytical procedures, for equivalency testing and for statistical evaluation. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Laboratory compliance, Analytical methods, data, procedures, compendial methods, Method validation and transfer, equivalency testing, FDA inspection, SOPs, FDA and EU compliance
43.
 
FDA's Medical Device Software Regulation Strategy
ID
885117
Dates
21 Sep 2017 - 22 Sep 2017
Location
Boston, United States
Abstract
The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
Seminar by Ex-FDA Official, Regulatory profile for software products, FDA mobile apps regulation, medical device software functionality, FDA and NIST software guidance
44.
 
22nd International Conference of FFC- Functional Foods and Chronic Diseases: Science and Practice
ID
876602
Dates
22 Sep 2017 - 23 Sep 2017
Location
Boston, United States
Abstract
Functional Food Center is pleased to announce its 22nd International Conference
Contact
Email: ffc@functionalfoodcenter.com
Topics
functional foods, chronic diseases, diabetes, CVD, obesity, cancer
45.
 
PHARMATechExpo — VIII International Exhibition of Equipment and Technologies for the Pharmaceutical Industry
ID
877317
Dates
17 Oct 2017 - 19 Oct 2017
Location
Kiev, Ukraine
Abstract
The only one Exhibition in Ukraine where is presented the entire pharmaceutical production process: from development of substances and quality control of raw materials, equipment for pharmaceutical production and packaging technologies to transportation, storage of pharmaceuticals and staff recruitment. During the exhibition, in the framework of the scientific-practical program Days of pharmaceutical industry will be held conferences, seminars, round tables and presentations.
Contact
Olga Babii;     Phone: [+380442061015];     Email: expo@pharmatechexpo.com.ua
Topics
raw materials and components, production and nonproduction equipment, packing and packing equipment, сlean rooms technologies, technologies and equipment for water supply, water treatment and sewage treatment, industrial refrigeration and climatic equipment for pharmaceutical enterprises, staff training and educational institutions, services for pharmaceutical companies
46.
 
Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices
ID
885083
Dates
09 Nov 2017 - 10 Nov 2017
Location
Cambridge, United States
Abstract
Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the regulators that demands, in turn, that industry be keenly aware of the legal and regulatory duties, as well as key recent trends in enforcement activities by the Federal Government. This course will explore in detail what FDA requires of drug and device firms as well as recent current hot buttons in FDA enforcement activity for the advertising arena. What’s at stake if your advertising and promotional efforts violate the law? Colossal fines – the latest was $3 Billion; criminal liability, including even prison time; and huge disruption in operations while dealing with federal probes into illegal marketing. Note: Use coupon code NB5SQH8N and get 10% off on registration.
Contact
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics
FDA training seminar, FTC advertising seminar, advertising drugs, advertising medical devices, promotion drugs, promoting medical devices, FTC advertising rules

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Last updated: 23 March 2017