MODULE REGISTRATION: Idea – first steps / Introduction to the Biomedical Translation Pathway
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14 Veranstaltungen wurden gefunden.
Veranstaltungen
Health System and Framework of the Programme
TWINCORE Feodor-Lynen-Str. 7, 30625 Hannover, Hannover, Germanylsdkfjsldkjsf
Introduction to the legal system
TWINCORE Feodor-Lynen-Str. 7, 30625 Hannover, Hannover, GermanyLecturer: 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
Methods for successful project management
TWINCORE Feodor-Lynen-Str. 7, 30625 Hannover, Hannover, GermanyLecturer: 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
Development of a Taget Product Profile by Serum Life Science Europe GmbH
TWINCORE Feodor-Lynen-Str. 7, 30625 Hannover, Hannover, GermanyLecturer: 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
Industrial property rights
TWINCORE Feodor-Lynen-Str. 7, 30625 Hannover, Hannover, GermanyLecturer: 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
Patents
TWINCORE Feodor-Lynen-Str. 7, 30625 Hannover, Hannover, GermanyLecturer: 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
Licenses & Cooperation Agreements
Online via ZoomLecturer: 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
Introduction to small molecule research and development
Online via ZoomLecturer: Prof. Mark Brönstrup, Helmholtz Centre for Infection Research Description: Contributions of small molecules in medicine, development phases and decision points. Overview of strategies for identifying lead structures. Course duration: 1 hour Language: English
Introduction to the basics and principles of quality management
TWINCORE Feodor-Lynen-Str. 7, 30625 Hannover, Hannover, GermanyLecturer: Dr. Henning Voigt, Medical School Hannover (MHH) & Dr. Jens Gerdelmann, Fraunhofer Institute for Toxicology and Experimental Medicine (Fraunhofer ITEM) Description: Introduction to quality management, quality assurance and quality control. Topics include QM principles, organizational structures and processes, responsibilities, process orientation, continuous improvement, documentation, validation and qualification, risk analysis, audits and inspections, change and deviation management, CAPA, as well as GxP, accreditation and certification. Course duration: 4 hours and 20 minutes Language: German with English Translation
Role of quality management in good scientific practice and clinical translation
Online via ZoomLecturer: Dr. Henning Voigt, Medical School Hannover (MHH) Description: Role of Good Scientific Practice as part of GxP at the interface between basic research and clinical translation. Topics include GxP compatibility, risk-based project analysis, quality aspects related to personnel, facilities, equipment, methods, materials and documentation, and the question of when quality is “good enough” for the translational pipeline. Course duration: 1 hour and 30 minutes Language: German with English Translation
Quality assurance in non-clinical safety testing: Introduction to good laboratory practice
Online via ZoomLecturer: Dr. Jens Gerdelmann, Fraunhofer Institute for Toxicology and Experimental Medicine (Fraunhofer ITEM) Description: Introduction to Good Laboratory Practice: scope and regulatory background, GLP principles, organizational structure of a test facility, facilities and test systems, SOPs, conduct of GLP studies, QA inspections and regulatory oversight. Course duration: 1 hour and 30 minutes Language: English
GMP – Good Manufacturing Practice
Online via ZoomLecturer: N.N. Description: More information will be provided later Course duration: 2 hours Language: English
Risk management
Online via ZoomLecturer: Dr. Carmen Puschmann, corlife oHG Description: This information will be provided later Course duration: 1 hour and 30 minutes Language: English