4 April 2016
Kfar Maccabiah, Ramat Gan
SKU: 16950S
Description/Topics to be covered during this course
- Presentation of regulatory framework (in EU and US): product definition, regulatory pathway, opportunities to interact with regulators, incentives to ATMPs development
- Feedback on registered cell-based and tissue engineered medicinal products so far in EU and US
- CMC development: Regulatory and technical CMC specificities and challenges faced during the development of a cell/tissue therapy (viability, identity, purity, potency, viral safety, stability…); Main differences between the EU and US CMC regulatory expectations, Case studies
- NC and C development: Specificities of the non-clinical (and clinical) development of a cell/tissue therapy (risk based approach) for example selection of animal model, bio distribution, tumorigenicity, Main differences between the EU and US nonclinical regulatory expectations, Case studies
- Key questions for an effective regulatory roadmap to support a global development? Pitfalls to avoid
- Q&A
Who should attend
- Regulatory Professionals
- CEO of companies developing cell or tissue based products
- R&D professional
Price:
| Category |
Registration & Payment Fees
before March 21, 2016 |
Registration & Payment Fees
after March 22, 2016 |
| Regular participant |
1150 NIS +VAT |
1350 NIS +VAT |
| Student |
600 NIS + VAT |
690 NIS + VAT |
|
|
Speaker/Lecturer :
Anne Dupraz Poiseau, Ph.D., Executive Vice President, Voisin Consulting Life Sciences
Dr. Anne Dupraz-Poiseau is Executive Vice President at VCLS, France. Anne has a global strategic role within VCLS focused on the development of services for cell based and human tissue engineered medicinal products as well as drug/device combination products. She has expertise in and works on the design and implementation of regulatory strategies. Anne manages multidisciplinary teams dedicated to complex and innovative healthcare product development programs, including for regenerative and personalized medicine.
Read more
