Meetings/Workshops on Regulation in Medicine and Pharmacology in the United States (USA)

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1
5th Annual ComplianceOnline Medical Device Summit 2020
16 Apr 2020 - 17 Apr 2020 • Boston, United States
Organizer:
ComplianceOnline
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.
Contact:
Phone: [18887172436];     Email: referral@complianceonline.com
Event listing ID:
1307149
Related subject(s):
2
The Risk-Based Approach to Pharmacovigilance Audits - A Practical Approach to Design and Implementation
20 Apr 2020 - 21 Apr 2020 • San Francisco, CA, United States
Organizer:
Complianceonline
Abstract:
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 has to cover all PV processes and tasks undertaken by or delegated to other departments, Marketing Authorization Holder affiliates, and third parties such as distributors, external service providers, licensing partners. In other words, has to cover all PV Universe. The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule. Using risk-based approach to develop an audit strategy, companies can conform to the regulatory requirements and business needs. But the questions remain: How to do it? Where to start? How to improve? What are the best industry practices?
Contact:
Phone: [18887172436];     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, PV Audit Strategy Plan, PV processes and activities, Safety data exchange agreements (SDEAs), vendor contracts, SOPs, Procedure Documents
Event listing ID:
1329180
3
Designing and Sustaining New and Existing Product Stability Testing Program
23 Apr 2020 - 24 Apr 2020 • Tampa, FL, United States
Organizer:
Complianceonline
Abstract:
This seminar will provide a great resource to Pharmaceutical, Biotechnology, Diagnostics, Cell Therapy, Drugs, Biologics, OTC, Radio-pharmaceutical, Pharmacies and Medical Device Industries in understanding the effective way to establish a new or modified product stability testing program. This program is an important part of a product's regulatory filing requirements as well as the determination of the shelf life or expiration date of the product. This is an important part of every business final bottom line or indirectly relationship to their supply and warehouse chain (how long the product can be stored before it can be discarded). Understanding how to design and implement an effective stability testing program following the regulatory guidelines will allow the product to be manufactured, tested, released, adequately stored and effectively tested for stability and ultimately used through its actual end point based on the product's potency. This will eliminate potential loss of product and business income by manufacturers of product (i.e. when a potent product is inadvertently discarded due to a poorly designed stability testing program) which ends up impacting the products' regulatory filing status or a product's Regulatory Filing/Application. The focus of this seminar will create a detailed process that will guide the attendees in the right direction in the planning of a new or existing product's stability testing plan, program, protocol, handing and utilizing the data, setting the shelf life as well as the applicable regulatory requirements.
Contact:
Phone: [18887172436];     Email: referral@complianceonline.com
Event listing ID:
1334529


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Last updated: 21 February 2020