Summary
This 2-day course will provide you with a comprehensive overview of clinical, quality, regulatory and organisational aspects of clinical trials for Advanced Therapeutic Medicinal Products. You will receive a regulatory update, explore regulatory pathways and procedure types as well as recommendations for common hurdles.
Learning Objectives
- Regulatory expectations for ATMP products
- Practical implementation of regulatory expectations & a comprehensive regulatory update
- Understand the GxP requirements for ATMPs
- Take advantage of the available regulatory advice
- Understand different procedure types (legal, timetables, etc.)
Key Topics
- Regulatory: Overview, Framework, Expectations & 2022 Update
- ATMP Procedures (Types; Centralised, National)
- The Medicinal Product Life Cycle (ATMP)
- GxP Requirements
- Marketing Authorisation
- Post- Authorisation/ Pharmacovigilance
Who should attend?
- Clinical Research Associates
- Clinical Scientists
- Clinical Operations Analysts
- Clinical Diagnostic Specialists
- Clinical Trial Managers
- Regulatory Managers & Specialists
- Drug Development Scientists
- Quality & Compliance Associates
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 30 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
Dr. Rensing studied biology and medicine biology and medicine at Tübingen, Heidelberg and Amherst, USA. During his clinical career he contributed to more than 40 clinical trials in all phases. He has worked in hospital management and more importantly in the pharmaceutical industry as well as at The Paul-Ehrlich-Institute (PEI) as a clinical assessor.
Prof. Schönermark studied Medicine at the universities of Göttingen, Munich, Heidelberg, London and Cape Town After PhD, and spent post doc time and various stays abroad, including at Columbia University in New York and Dartmouth Medical School, Hanover NH, Specialist examination for ENT medicine and activity as Managing Senior Physician at the Ear, Nose, Throat Clinic Hannover Medical School followed by further training in systemic therapy Postgraduate Certificate in Neuro Leadership.
ATMP Clinical Trials – The Medicinal Product Life Cycle & Regulation
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
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