CMC SPIN Webinar & Q&A Session - Pharma Combination Products

CMC SPIN Webinar & Q&A Session - Pharma Combination Products
TOPRA CMC SPIN is pleased to introduce this free members-only webinar on ''Pharma Combination Products: Hot topics in evolving US/EU regulation'', which will be held on 13 June 2018 from 2-3.30 pm BST (British Summer Time).

Date: 13 June 2018

Time: 2.00 PM – 3.30 PM BST  (British Summer Time)  

Spaces are limited. Register today to avoid missing out!

We are pleased to inform you that this free webinar will be presented by Doug Mead (J&J), Amanda Matthews (Pfizer), Deborah Schachter (J&J) and Peter Eijgenhuijsen (J&J).

This webinar will provide considerations with regard to the changing regulatory landscape for pharmaceutical combination products and will cover the following:

• Increasing FDA/EMA expectations on device development and performance requirements
• Content and strategy in regulatory dossiers (both for marketing and clinical trial applications)
• Uncertainties regarding the expectations of Notified Body assessments in Europe
• Challenges in the positioning of platform delivery devices

In order to get full benefit out of this webinar and the Q&A session please submit your questions in advance to Deborah Schachter on DSchacht@its.jnj.com before 4 June 2018

To book: This webinar is now full, please email membership@topra.org to join the waiting list
When
13/06/2018
Where
Webinar- At Your Desk
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