28 September - 15.00-16.00 BST

Advanced (cell and gene) therapy medicinal products (ATMPs) initially started out as a potential therapy for the lucky few in orphan disease settings. This picture has evolved dramatically over the years. The current ATMP armentarium continues to grow and the pipeline is expanding far beyond the last line (haemato-)oncology setting. Despite this huge success story, the developmental path is far from a smooth ride. Getting an ATMP from bench to bedside comes with its own specific, complex challenges. 
Such a complex developmental arena requires ingenuity. This webinar will explore some of the the current opportunities to smoothen the developmental path in ATMP development, such as decentralised manufacturing, making use of the hospital exemption (specific for the EU), early incorporation of device and diagnostics into the overall development plan and accommodating the growing request for comparative results by various stakeholders in drug development.

Who should attend?
1. Physicians and Principal Investigators
2. Experts from Regulatory Agencies and Pharma industry, specifically with the following background:
1. Quality, Manufacture and Control 
2. Medical Device and In Vitro Diagnostics 
3. Clinical 
4. Regulatory
3. And others involved or interested in Cell and Gene Therapy development

Speakers
Paula van Hennik, Clinical Group Head, Regulatory Sciences, ProPharma

Paula van Hennik has 10+ years of experience in regulatory affairs, including serving as an alternate CHMP member on behalf of the Dutch Medicines Evaluation Board and as a Senior Clinical Assessor at the Dutch Medicines Evaluation Board. Prior to that, she spent several years in research as a postdoc and research group leader in The Netherlands studying molecular mechanisms of hematopoietic (stem) cell migration and was awarded several competitive public research grants. Paula has a PhD in hematology on in vivo and in vitro hematopoietic stem cells assays from Erasmus University in Rotterdam, The Netherlands.

Jens van Wijngaarden, Director, Regulatory Sciences, ProPharma

Jens van Wijngaarden has over 15 years’ experience in regulatory affairs, both as a regulator as well as an independent consultant. In the Dutch Medicines Evaluation Board (MEB), he was principal advisor of staff and the scientific advice department. He also was the NL member of the EU innovation network and Dutch ATMP Committee. Together with a PhD in molecular biology he combines his scientific background with top-end regulatory affairs expertise.

This webinar is sponsored by  ProPharma

Disclaimer: Whilst TOPRA is running this webinar for ProPharma, this is not an endorsement of ProPharma, ProPharma's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.

How do I register?

Simply log in or create an account and register below.

Pricing

• Members: free
• Non-members: free

Terms and Conditions

By purchasing this webinar, you are agreeing to TOPRA's training terms and conditions.