Idea - First steps - Introduction to the Biomedical Translation Pathway

Here you can register for all events in this module.

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Lecturer: Peter Lotz, Attorney, MAYRFELD Rechtsanwälte & Attorneys-At-Law Description: Introduction to the basic regulatory requirements for manufacturing and marketing different types of therapeutic products, including related complexity and costs. The session covers legal classification and differentiation of medicinal products, medical devices, ATMPs etc., as well as requirements for manufacturing, quality management and post-market surveillance. Course duration: 2 hours Language: English

Lecturer: Dr. Leander Grode, Serum Life Science Europe GmbH Description: Introduction to project planning and project management for translational projects. Key topics include reverse planning, defining the final goal, deriving a Target Product Profile, planning backwards from clinical development to preclinical work and GMP production, as well as milestones, deliverables and tracking tools. Course duration: 2 hours Language: English

Lecturer: Dr. Gerald Parzmair & Dr. Fabio Pisano, both from Serum Life Science Europe GmbH Description: Development of a Target Product Profile: purpose, structure and content of the TPP document and its relevance for a translational development plan. The course builds on project planning and project management and enables participants to develop a TPP for their own product or research project. Course duration: 2 hours and 15 minutes Language: English

Lecturer: Dr. Ralf Cordes, Ascenion GmbH Description: Introduction to intellectual property rights, novelty, industrial applicability, patent procedures and practical recommendations Course duration: 1 hour Language: English

Lecturer: Dr. Stefan Taruttis, Patent Attorney, Tarrutis Patentanwaltskanzlei Description: Overview of the relevance of patents, substantive requirements, possible filing strategies and enforcement of patents through infringement proceedings. Course duration: 1 hour Language: German with English Translation

Lecturer: Peter Lotz, Attorney, MAYRFELD Rechtsanwälte & Attorneys-At-Law Description: Introduction to the types of licensing and cooperation agreements. The session covers key elements of a license, differences between in-licensing and out-licensing, objectives and typical elements of cooperation agreements, and why such agreements can already play an important role during early idea development. Course duration: 1 hour Language: English