Conférences - Législation en médecine et pharmacologie

Complianceonline

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is responsible for the approval of veterinary drug products intended for family pets, food-producing animals, and other animal species. This seminar will cover the process for obtaining federal government approval for marketing new animal drug products that are under the jurisdiction of the FDA, and also briefly covers animal products that are regulated by other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture, and some flea and tick control products are regulated by the Environmental Protection Agency.

This three-day interactive seminar will provide attendees with an understanding of FDA’s veterinary drug approval process. The group size is small, generally between 8 and 20 people, with plenty of opportunities to ask questions and discuss issues or challenges that the attendees have experienced.

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, APHIS, NADA, FDA’s rules governing chemistry, animal field study, FDA compliant label, labeling, marketing, advertising, animal feed, veterinary devices, OTC drug products, FDA's product centers, Center for Food Safety and Applied Nutrition (CFSAN), Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Tobacco Products, Center for Veterinary Medicine (CVM), environmental Impact (EA/CE), container Closure System, stability, Veterinary Clinical Trials, Animal Drug User Fees and Related Fee Waivers, 21 USC, 303 and 307

HubPlus Events

Pharmacy Career Conference is conceptualized for Pharmacy Students and Professionals who would like to explore the non-traditional pharmacy career options. The students and professionals who attend this conference would get an opportunity to meet industry stalwarts who will share their strategies and challenging stories in pursuing non-traditional pharmacy career options and learn on the current market trends and various opportunities within the sector. The conference would witness a series of interesting sessions by the industry leaders with an aim to help freshers to understand the dynamics and develop the skills to keep themselves ahead in the race. The initiative will bring together students from various pharmacy colleges and Industry Mentors along with the Hiring Managers from top companies to help the students to make right career choices. This platform helps students to clear all their queries and enables them to broaden their mind to make right choices for their future.

Attendee Enquiries;     Tél.: [+971 4 299 9398];     Email.: nina@hubplus-events.com

Pharmaceuticals, Pharma, Medicine, Medical, Career Development

Pharmacologie et développement des médicaments,    Formation médicale continue (FMC)

Complianceonline

Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood the extent of the commitments we make when we write an SOP or how the writing of the SOP can have a positive or negative impact on training or job performance. For example, there is an expectation that procedures describe the most critical processes for product manufacturing and will be followed consistently, with few if any deviations. In this course you will learn the keys to writing effective SOPs, the vital connection between the documentation and training spheres, and how to maximize this connection to improve the quality of both SOPs and training.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

Complianceonline

The objective of this two day ComplianceOnline seminar is to explore and define the necessary elements in the development and implementation of a Data Integrity program and how to maintain Quality Systems that minimize these issues. This seminar is designed to assist in assuring that your organization is maintaining itself within cGMP compliance. Case studies to include Warning Letters will be discussed to illustrate the wide array of issues that continue to arise and how to find them within your organization and your vendors before the regulators find them for you. This seminar represents a great opportunity for a team from your Corporation to attend and mutually benefit each other.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

Complianceonline

Raw material requirements in a cGMP environment are often overlooked as a Company develops new products. Depending upon the product being developed, e.g., tablets and capsules vs. biotechnology products to include recombinant microorganisms and gene therapy products, as few as fifteen to twenty or as many as sixty raw materials need to be sourced before the process can be moved from initiation through completion.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

raw materials requirements, cgmp requirements for raw materials, raw material testing requirements, raw material requirements in a cgmp environment training, compendial and non-compendial testing, ICH Q9, health canada requirements

Complianceonline

This course provides attendees with an understanding of the role that Quality Agreements and DMFs play in the FDA's regulatory approval process for drugs and biologics. The course will take participants through a step-by-step process of when Quality Agreements are appropriate, how they should be prepared, formatting, content and negotiations around the agreement. The DMF section will explain content, format, preparation and the types of Drug Master Files which can filed in the U.S., as well as the EU, Japan and Canada. Additionally, this course explains why "one size does not fit all" and emphasizes the importance of customizing DMFs in both preparation and maintenance for particular products and businesses.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

Complianceonline

Please join us for this intense one-day program that will give you the skills to succeed as a case manager or social worker in the new era of value-based reimbursement and accountable care. The world of healthcare is changing so rapidly and so is the role of case management in that world! Whether you are reading or hearing about value-based reimbursement, the Affordable Care Act, the continuum of care, bundled payments, transitions in care, or accountable care organizations, case management is at the center of it all!

Complianceonline

Most of the focus on a laboratory’s compliance with Good Laboratory Practice (GLP) or with the analogous ISO 17025 is on items such as the Standard Operating Procedures (SOPs), training, quality assurance testing, and the statistical assessment of performance and compliance. These, however, are not all that an auditor may delve into. These might the bulk of an audit, yet a laboratory may still fail an audit while doing well on all of these areas. Since laboratories focus on these, other areas might be ignored – the more mundane and simple areas, such as recordkeeping and archiving, basic laboratory operations, and safety.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

Complianceonline

Quality Control (QC) Unit plays a critical role in assuring the identity, strength, quality, purity, and stability of drugs and biologics. QC Unit is responsible to approve or reject all procedures and specifications impacting quality, and all components, raw materials and the drug at all stages of manufacture, including intermediates, drug substance and drug product (21 CFR 211.22). Robust Laboratory Quality Management Systems (QMS) are essential to achieve and maintain sustainable regulatory compliance in a QC Unit. The course will start with an introduction to roles and responsibilities of QC Unit with an overview of Laboratory QMS, then focusing on key quality systems or issues, such as data of exceptions, including out of specifications (OOS), and Corrective and Preventive Actions (CAPA).

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

Virtue Insight

Virtue insight’s 26th Pharmacovigilance Conference is more than a traditional conference. It is a unique opportunity to learn about the latest trends, to engage with renowned experts, and to personally develop as a healthcare professional. Take this opportunity to learn from regulators and leading experts and discover what the challenges and opportunities will be in the field of Pharmacovigilance in 2021. Do not miss out on these exciting discussions. Join us virtually to discover and learn from the experts who will be joining us on 11th November 2021.

Email.: kavitha@virtueinsight.co.in

Pharmacovigilance, regulatory affairs, Drug Safety, Drug Development, patient safety, RiskManagement, Pharmaceuticals, healthcare

Complianceonline

This course will provide detailed explanations and examples for Building a Vendor Qualification Program for FDA Regulated Industry. With today’s pharmaceutical market, raw materials, Active Pharmaceutical Ingredients (API), Containers & Closures, inactive or excipients and other components are being sourced from all over the world. We also have Third Party Manufacturers and outside testing facilities that are part of our supply chains. Building and following a robust vendor qualification Program is essential for pharmaceutical and chemical manufacturers. We must create a procedure, which will be used to remain aware of the compliance status for all of our suppliers. Some raw material components may move from producers to brokers to the end users. In addition, there may be other shippers and wholesalers responsible for moving and holding our raw material components.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

Vendor qualification program, vendor requirements, off-site audit checklist, on-site verification form, vendor qualification, basics of quality system, FDA regulations

Complianceonline

In this two day workshop conference we will review the EMA and FDA requirements regarding Risk Based Audits of the PV system and Quality System. The course will focus on the design of the PV audit strategy, identification of the PV processes and entities subject to PV audit (define the PV audit universe), development of risk assessment methodology, development of procedures/tools to monitor PV processes and activities, and implementation of the PV audit strategy plan. Additionally, we will review methods of quality oversight and management of third parties performing PV activities.

Tél.: [+1-888-717-2436];     Email.: referral@complianceonline.com

pharmacovigilance audit strategy planning, good pharmacovigilance practices, pv audit strategy plan, risk based pharmacovigilance audits, pharmacovigilance audit plan, fda pharmacovigilance audits, pharmacovigilance audit checklist, pharmacovigilance auditing training, fda pharmacovigilance inspections

HubPlus Events

ACRAS 2021 is the platform for Regulatory affairs Officials and Industry Leaders to discuss Regulations and Legislation to improve the application for products and procedures to enhance the safety for the Medical Professionals and their patients in the Middle East. The summit is scheduled to be hosted virtually from the 24th-25th of November 2021 and will deliver senior executives from international and regional Aesthetic and cosmetic companies, regulatory bodies to brainstorm, benchmark and debate the impacts that new regulations are having on the market. With top international & local experts in the Aesthetics & Cosmetic segment and Industry players focusing on product approvals and access in the Middle East markets, the platform provides industry leaders to set up in the region, expand or launch their latest range of innovative products or services.

Attendee Enquiries;     Tél.: [+971 4 299 9398];     Email.: nina@hubplus-events.com

Cosmetic, Regulatory Affairs, Cosmetology, Aesthetics, Plastic Surgery, Cosmetic Regulatory Affairs, ACRAS, ACRAS2021, Aesthetic & Cosmetic Regulatory Affairs Summit