Understanding the implications of the EU legislative proposal is vital for all stakeholders in academia and industry involved in the research and development of tissue-engineered products. To provide guidance on the proposed Regulation on advanced therapies, including GCP and GMP requirements, the BIA Regulatory Affairs Advisory Committee (RAAC), is holding a one-day seminar.
The seminar will predominantly focus on tissue-engineered products - the challenges of the development of a regulatory framework, which aims at controlling these products by extending the scope of the regulation for advanced therapy medicinal products.
Dr Pekka Kurki, Chairman of the EMEA Cell-based Product Working Party will explain the preparatory steps the EMEA has taken in order to regulate this new class of biotech products, whilst experts from the MHRA (Medicine and Healthcare products Regulatory Agency) will advise on how to approach the GCP and GMP requirements.
The seminar also aims to demonstrate the current experience in developing tissue-engineered products from industry and academia perspective as well as covering aspects of human embryonic stem cell research. The event will be attractive to a wide variety of different stakeholders, keen to air their personal views via the organised discussions. Through their participation and the collective expertise of the panel, an increased dialogue and sharing of experience and concerns will enhance the attendees’ in-depth expertise and knowledge of this evolving and exiting area.
For the programme of the seminar, go to http://www.bioindustry.org/biodocuments/BIA_RAAC_May06.pdf
To register, go to https://www.bioindustry.org/cgi-bin/events.pl?CD=41214
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