A forum is an interactive platform for discussion and information and will be filled by contributions out of the Special Interest Groups. Special Interest Groups provide an opportunity for direct interaction with your peers in specialized fields.

Registration form to become member of a SIG: here

SIG "Regulatory Aspects during Biopharmaceutical Development"
This Special Interest Group intends to openly discuss between regulatory experts and industrial CMC experts the burden versus the benefits of the new philosophy and targets at giving in the end some guidance to the participants in the Working Group and outside (via white papers).

In combination with the biotech trade fair Biotechnica  EAPB holds its next workshop of regulatory aspects on October 4, 2010
In contrast to many other sciences, the biopharmaceutical sciences are heavily impacted by national and international regulations so that developers and manufacturers of biopharmaceutical drug substances and drug products need profound knowledge of the current drug regulations in the field as well as of current regulatory opinions. On the other hand, drug regulations must consider what is scientifically feasible and sensible. This balance is achieved the best by frequent exchanges between industry, academia and regulatory bodies.

The SIG Regulatory Aspects for Biopharmaceuticals wants to give this exchange room and targets at taking up current hot topics in presentations and discussion forums.

The aim of this workshop is to bring together experts on regulation and experts from academia and industry in order to share experiences and discuss different opinions on two selected current hot topics: "Quality by Design" and "Subvisible Particles".

Detailed program will be published during July 2010.
Registration

Location: Biotechnica - Hannover Messe
Time: October 4, 2010, 1:30 - 5:30 pm

If you are interested in contributing as a speaker, please contact managing.director@eapb.org.

Registration form to become member of a SIG: here
http://eapb.org/index.php?id=26Registration form to become EAPB member

SIG "Regenerative Medicine"
The mission of this group is to promote the discussion and distribution of new information related to one or two topics in this field per year. Within the first year we will discuss current developments in stem cells technology for non- and therapeutic applications addressing in this regard also questions relating to manufacturing and regulatory processes. In the forthcoming years all members of the group will decide on the next topics which should be discussed.
Our goal is to create a bridge and network between scientists working in the fields of regenerative medicine, stem cell biology, and drug discovery.

In combination with the biotech trade fair Biotechnica EAPB holds its next SIG of regenerative medicine on October 4, 2010
Advanced Therapy Medicinal Products (ATMPs) are tightly regulated by the European Medicines Agency (EMA) with the intention to ensure the safety, efficacy as well as the good quality of the products. A well defined risk evaluation in order to cover the whole development process and not only quality or safety risks should be set-up. For example, tumorigenicity, genome stability, biodistribution are now among the top issues during non-clinical and clinical development and need to be addressed for stem cell-based products early. A key point is hereby an efficient communication with the regulators as early as possible to avoid detours or even worst failures. So the scientific advice became a very powerful tool to find the right way through the jungle of guidelines, reflection papers, regulations and the expectation of the regulators.

The aim of this workshop is to bring together experts on regulation and developers from academia and industry in order to share experiences and handy tips for the process of scientific advice by regulatory agencies and for the development of cell-based products in Europe. 

Presentations will be about the significance of scientific advice for small enterprises and the "dos and donts" during the process of scientific advice as well as quality standards of stem cell based therapies.

Detailed program will be published during July 2010.
Registration

Location: Biotechnica - Hannover Messe
Time: October 4, 2010, 1:30 - 5:30 pm

If you are interested in contributing as a speaker, please contact managing.director@eapb.org.

Registration form to become member of a SIG: here
Registration form to become EAPB member