Using an eDMS to enable EU-compliant batch release of medicinal products

28 April 2021 | Online

Catch the latest updates on how to be efficient and compliant when managing registered details in more than one market. 

Annex 16 of the European Union (EU) Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use provides detailed requirements for batch certification and release. A key stipulation for batch release by the Qualified Person is confirmation that the batch being released has been manufactured in compliance with the requirement of its marketing authorization, regardless of whether the batch is intended for patients within the EU or for export. Management of these registered details can be challenging, especially for complex supply chains, or when registered details differ between markets. One solution is to utilize an electronic document management system (eDMS) to store, organize, update and track registered details. The presentation will provide an overview of how an eDMS can be used to manage registered details in multiple markets to enable compliance with Annex 16 expectations.

Meet the Speakers

David Gwyn

Vice President, Amplexor Life Sciences

With more than 25 years of experience in the Life Sciences industry, David Gwyn is a seasoned executive with extensive experience. As a Vice President for Amplexor Life Sciences, David’s main focus is aligning customer needs with the capabilities of the company’s Life Sciences Suite to ensure that the solution meets the needs of the customer.

Dave Yates

Director Regulatory Affairs CMC & Operations, Abbott

Dave Yates has over 20 years of experience in the Pharmaceutical Industry; spending 8 years as a formulator of ethical pharmaceuticals before gaining extensive regulatory experience managing Global pre and post-approval activities for Ethical and OTC medicines across multiple therapeutic areas. He has held Director-level leadership roles for the last 8 years managing global regulatory teams responsible for innovation projects and lifecycle maintenance of medicines and medical devices. He is from the UK but has been working abroad for the past six years, firstly in Singapore and currently in Switzerland where he heads the CMC Regulatory and Regulatory Operations functions within the Established Pharmaceuticals Division of Abbott.


Using an eDMS to enable EU-compliant batch release of medicinal products

April 28 2021 | 3:00 pm - 4:00 pm CEST

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