Programm

Only for EKFZ Academy members

Dr. Karsten Gavenis, Dr. Thomas Asendorf, Dr. Florian Walker (Clinical Trial Unit UMG)

Krishyanthy Sritharen (Fraunhofer Institute for Translational Medicine and Pharmacology ITMP)

• The workshop “How to conduct a clinical trial in accordance with good clinical practice” provides an overview of the requirements for clinical trials. It discusses the classification of different types of trials, their regulatory differences, and the impact on the respective trial design and study conduct. Important aspects of planning and implementation are discussed, such as the statistical aspects of case number planning, power calculation, and outcome, as well as endpoint determination. Regarding study conduct, emphasis is placed on the most important points of preparation and practical implementation, including pitfalls.

Only for EKFZ Academy members

Dr. Sabine Hauck (dequra consulting sabine hauck)

• Translational science from lab to clinics comes with the requirements of GxPs – a set of Good Practices. Manufacturing of a material for testing in a clinical trial has to follow the Good Manufacturing Practice (GMP). This course on „GMP for the manufacture of ATMPs“ will provide an introduction into the requirements of these GMPs and highlight specific points to consider for interaction with contract manufacturers.

Only for EKFZ Academy members

Prof. Dr. Rabea Hinkel (German Primate Center)

Dr. Ramona Brecht (EKFZ)

Jana Sie (EKFZ)

• Animal experiments are an integral part of preclinical development and help to assess the safety and efficacy of new drugs. However, numerous regulatory restrictions need to be considered when conducting animal experiments. In the EKFZ Academy course “Regulatory frameworks for animal research – best practices and challenges”, veterinarians Rabea Hinkel, Ramona Brecht and Jana Sie will guide the Academy members through the legal regulations. They will provide important insights into the regulatory requirements for experiments with primates and give valuable tips for writing a successful animal experiment application. Furthermore, workshop participants have the opportunity to attend a guided tour through the outdoor facilities of the German Primate Center.

Open to all EKFZ-associated members

Dr. Stefan Uhle (MBM ScienceBridge)

Markus Rieck & Dr. Nico Riffel (Fuchs Patentanwälte)

Dr. Lennart Weiß (KWINTELY Intelligence)

• Gain valuable insights into the patent system and learn how to successfully protect and utilize your ideas and innovations! In this workshop, intellectual property experts from MBM ScienceBridge and Fuchs Patentanwälte will provide strategies for the successful exploitation of scientific inventions and explain the basics of patent application and law. Workshop participants will also learn how patent search can be simplified and accelerated by using the software KWINTELY. Afterwards, participants have the opportunity to discuss their own inventions with the professionals while enjoying drinks and finger food.

Only for EKFZ Academy members

Jörn Lindemann (SNIC Life Science Inkubator)

Dr. Martin Strehle (Life Science Factory)

Angela Bortenreuter (Translationsallianz in Niedersachsen TRAIN)

• A broad regional network of players from science and industry is crucial for the successful translation of innovative research into clinical use. In the workshop “Translation and startup ecosystem in Lower Saxony”, workshop participants will gain insights into Lower Saxony's life science ecosystem and meet several key players. Jörn Lindemann (SNIC Life Science Inkubator), Dr. Martin Strehle (Life Science Factory) and Angela Bortenreuter (TRAIN) will present their organizations and provide valuable glimpses of their translational work. Afterwards, you will have the opportunity to network and exchange ideas with the speakers while enjoying drinks and ice cream.

Only for EKFZ Academy members

Dr. Timo Faltus, Carsten Fluck, Johannes Freise, Dr. Hans Zillmann (NeurOPTICS research project team, Martin Luther University Halle-Wittenberg)

• The NeurOPTICS research project team will provide workshop participants with insights into the ethical and legal debate surrounding neuronal optogenetics. Two workshops will deal with two central aspects of research in the field of neuronal optogenetics: The ethical and legal aspects of animal research (Workshop A) and the ethical and legal aspects of clinical research (Workshop B). In both workshops, the participants will deal with central arguments of the respective ethical and legal debate. The two workshops will be followed by a get-together at which the topics of the two workshops will be presented to all participants.