Paul-Ehrlich-Institut

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2-day Work­shop – GMP-com­pli­ant Man­u­fac­tur­ing of COVID-19 Vaccines

Vaccine development and deployment are crucial to control the COVID-19 pandemic. Platform technologies have enabled rapid development of vaccines with demonstrated efficacy against COVID-19. However, large-scale manufacturing is both a prerequisite and a challenge in meeting the global demand. This implies upscaling of manufacturing, meeting Good Manufacturing Practice (GMP) requirements, and switching of manufacturing in existing facilities.

The workshop organised by the Paul-Ehrlich-Institut and the ECA Foundation will address these topics and provide an overview of issues related to GMP manufacture of vaccines and practical insights from experts in the field.

The objective is to provide a training opportunity for inexperienced staff and a discussion forum for experienced personnel on specific COVID-19 vaccine-related questions.

Besides the above-mentioned topics the invited speakers will cover GMP issues, microbiological and viral safety aspects, QC and environmental monitoring aspects as well as important regulatory issues and framework.

The workshop will be held virtually and will take place from 10 to 11 March 2021.

About the Paul-Ehrlich-Institut

The Paul-Ehrlich-Institut is the German Federal Institute for Vaccines and Biomedicines, responsible for research, assessment and marketing authorisation of biomedicines for human use and immunological veterinary medicinal products. Its remit also includes the authorisation of clinical trials and pharmacovigilance, i.e. monitoring and evaluation of potential adverse effects.

Other duties of the institute include official batch control, scientific advice and inspections. In-house experimental research in the field of biomedicines and life science form an indispensable basis for the manifold tasks performed at the institute.

The Paul-Ehrlich-Institut, with its roughly 800 members of staff, also has advisory functions nationally (federal government, federal states), and internationally (World Health Organization, European Medicines Agency, European Commission, Council of Europe etc.).

www.pei.de

About the ECA Foundation

Founded as an independent non-profit organisation in 1999, the ECA Foundation is Europe’s leading association for pharmaceutical Quality Assurance and GMP compliance. Its goal is the exchange of information between representatives in industry, regulatory authorities and universities in the field of pharmaceutical quality assurance, especially with regard to the area of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). For this purpose the organisation has set up several Interest Groups and Working Groups as well as an Academy for advanced education. Individuals can become members of the ECA Groups and in the Academy. In total, more than 7,000 professionals have joined the ECA organisation. Its largest group, the European Qualified Person Association, alone accounts for close to 3,200 QPs. The ECA Foundation Groups developed a range of tools like several Good Practice Guides.

www.eca-foundation.org

Updated: 23.02.2021