{"id":6448,"date":"2025-02-13T08:50:03","date_gmt":"2025-02-13T07:50:03","guid":{"rendered":"https:\/\/ekfz.uni-goettingen.de\/program\/"},"modified":"2026-03-13T12:19:59","modified_gmt":"2026-03-13T11:19:59","slug":"program","status":"publish","type":"page","link":"https:\/\/ekfz.uni-goettingen.de\/en\/program\/","title":{"rendered":"Program"},"content":{"rendered":"
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2026<\/h2>
22<\/div>
Apr<\/div><\/div>
Medical Devices \u2013 Quality and Approval at a Glance<\/span> | from 3:00 PM to 5:30 PM<\/span><\/div>+<\/span><\/div>

Only for EKFZ Academy Members<\/h4>\nSpeaker<\/strong>\n
    Dr. Sabine Hauck (dequra consulting sabine hauck)<\/ul>\nDescription<\/strong>\n
      \n \t
    • How can approval for medical devices be achieved in a complex regulatory environment? The interactive EKFZ Academy workshop \u201cMedical Devices \u2013 Quality and Approval at a Glance\u201d guides you through the regulatory requirements and provides a comprehensive overview of product development and documentation. Dr. Sabine Hauck will discuss the differences between medical devices and medicinal products, as well as the regulatory framework in the USA and the EU. She will also provide valuable insights into product development, with a focus on quality management and documentation. Afterwards, workshop participants will have the opportunity to network and discuss open questions with Sabine Hauck while enjoying drinks and finger food. \n<\/li>\n<\/ul><\/div><\/div><\/div><\/div>
      21<\/div>
      Jan<\/div><\/div>
      Scientific advice by the Paul-Ehrlich-Institut and the Committee for Medicinal Products for Human Use<\/span> | from 3:00 PM to 5:00 PM<\/span><\/div>+<\/span><\/div>

      Open to all EKFZ-associated Members<\/h4>\nSpeakers<\/strong>\n
        Dr. Jens Reinhardt (Paul-Ehrlich-Institut)<\/ul>\nDescription<\/strong>\n
          \n \t
        • How can a promising new research result be translated from the bench to bedside?\nWhat are the regulatory challenges and how can they be maneuvered?\nHow are regulatory authorities supporting this process?\n\nDr. Jens Reinhardt, a regulatory scientist at Paul-Ehrlich-Institut and a member of the Scientific Advice Working Party of the European Medicines Agency (EMA), is presenting the advice possibilities given by the upper regulatory agencies in Germany and the Scientific Advice at EMA.\n He will explain the remits and the procedures of the agencies and give examples on dos and don\u2019ts of advices. The presentation is intended for researchers looking to translate their research into clinical application and everybody interested in regulation of medicinal products. After the talk, workshop participants will have the opportunity to network and exchange ideas with Dr. Reinhardt while enjoying drinks and finger food. \n<\/li>\n<\/ul><\/div><\/div><\/div><\/div>

          2025<\/h2>
          17<\/div>
          Dec<\/div><\/div>
          How to conduct a clinical trial in accordance with good clinical practice (GCP)<\/span> | from 3:00 PM to 5:30 PM<\/span><\/div>+<\/span><\/div>

          Only for EKFZ Academy Members<\/h4>\nSpeakers<\/strong>\n
            Dr. Karsten Gavenis, Dr. Thomas Asendorf, Dr. Florian Walker (Clinical Trial Unit UMG)<\/ul>\n
              Krishyanthy Sritharen (Fraunhofer Institute for Translational Medicine and Pharmacology ITMP)<\/ul>\nDescription<\/strong>\n
                \n \t
              • The workshop \u201cHow to conduct a clinical trial in accordance with good clinical practice\u201d 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. <\/li>\n<\/ul><\/div><\/div><\/div><\/div>
                19<\/div>
                Nov<\/div><\/div>
                GMP for the Manufacture of ATMPs<\/span> | from 3:00 PM to 6:00 PM<\/span><\/div>+<\/span><\/div>

                Only for EKFZ Academy Members<\/h4>\nSpeakers<\/strong>\n
                  Dr. Sabine Hauck (dequra consulting sabine hauck)<\/ul>\nDescription<\/strong>\n
                    \n \t
                  • Translational science from lab to clinics comes with the requirements of GxPs \u2013 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. \n<\/li>\n<\/ul><\/div><\/div><\/div><\/div>
                    22<\/div>
                    Oct<\/div><\/div>
                    Regulatory Frameworks for Animal Research \u2013 Best Practices and Challenges<\/span> | from 3:00 PM to 5:30 PM<\/span><\/div>+<\/span><\/div>

                    Only for EKFZ Academy Members<\/h4>\nSpeakers<\/strong>\n
                      Prof. Dr. Rabea Hinkel (German Primate Center)<\/ul>\n
                        Dr. Ramona Brecht (EKFZ)<\/ul>\n
                          Jana Sie (EKFZ)<\/ul>\nDescription<\/strong>\n
                            \n \t
                          • 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 \u201cRegulatory frameworks for animal research \u2013 best practices and challenges\u201d, 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. <\/li>\n<\/ul><\/div><\/div><\/div><\/div>
                            2<\/div>
                            Jul<\/div><\/div>
                            Unlocking Innovation: the Strategic Power of Patents<\/span> | from 3:00 PM to 6:00 PM<\/span><\/div>+<\/span><\/div>

                            Open to all EKFZ-associated Members<\/h4>\nSpeakers<\/strong>\n
                              Dr. Stefan Uhle (MBM ScienceBridge)<\/ul>\n
                                Markus Rieck Dr. Nico Riffel (Fuchs Patentanw\u00e4lte)<\/ul>\n
                                  Dr. Lennart Wei\u00df (KWINTELY Intelligence)<\/ul>\nDescription<\/strong>\n
                                    \n \t
                                  • Gain valuable insights into the patent system and learn how to successfully protect and utilize your ideas and innovations!\nIn this workshop, intellectual property experts from MBM ScienceBridge and Fuchs Patentanw\u00e4lte 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. <\/li>\n<\/ul><\/div><\/div><\/div><\/div>
                                    4<\/div>
                                    Jun<\/div><\/div>
                                    Translation and Startup Ecosystem in Lower Saxony<\/span> | from 4:00 PM to 5:30 PM<\/span><\/div>+<\/span><\/div>

                                    Only for EKFZ Academy Members<\/h4>\nSpeakers<\/strong>\n
                                      J\u00f6rn Lindemann (SNIC Life Science Incubator)<\/ul>\n
                                        Dr. Martin Strehle (Life Science Factory)<\/ul>\n
                                          Angela Bortenreuter (Translation Alliance in Lower Saxony TRAIN)<\/ul>\nDescriptions<\/strong>\n
                                            \n \t
                                          • 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 \u201cTranslation and startup ecosystem in Lower Saxony\u201d, workshop participants will gain insights into Lower Saxony's life science ecosystem and meet several key players. J\u00f6rn 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. <\/li>\n<\/ul><\/div><\/div><\/div><\/div>
                                            7<\/div>
                                            May<\/div><\/div>
                                            Ethical and Legal Challenges of Optogenetic Research<\/span> | from 9:30 AM to 1:30 PM<\/span><\/div>+<\/span><\/div>

                                            Only for EKFZ Academy Members<\/h4>\nSpeakers<\/strong>\n
                                              Dr. Timo Faltus, Carsten Fluck, Johannes Freise, Dr. Hans Zillmann (NeurOPTICS research project team, Martin Luther University Halle-Wittenberg)<\/ul>\nDescriptions<\/strong>\n
                                                \n \t
                                              • 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). \nIn 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. <\/li>\n<\/ul><\/div><\/div><\/div><\/div><\/div>[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_empty_space height=”55px”][\/vc_column][\/vc_row]\n<\/div>","protected":false},"excerpt":{"rendered":"

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