Combination Product
Half day seminar

Organized by Mark Kessler, Ph.D.

 

Date: 7 September 2014
Location: Kfar Maccabiah, Ramat Gan
Hours: 12:00-17:00
Registration: 12:00-12:30
SKU: P14728

This seminar is intended for drug manufacturers who are utilizing medical devices for delivery of their drug product.
It will provide an overview of FDA expectations and how they can be met from a quality, regulatory and business perspective.
Discussions will include examples of some of the issues that have been encountered in obtaining approval of combination products.

Seminar Program

Duration Topic Speaker
12:30 – 13:15 Registration & Lunch
13:15 – 13:30 Overview of FDA Guidance for Combination Products Mark Kessler, Ph.D.
Kessler Consulting, Ltd.
13:30 – 14:15 FDA Perspectives on Combination Products-PMOA, Jurisdiction and Pre-submission Program Hagit Marchaim, Ph.D.
VP RA Alcobra Ltd. and Regulatory Affairs Consultant
14:15 – 14:30 Coffee Break
14:30 – 15:15 Combination Products Require Two to Tango;
the Pharma - Medical Partnership
Tomer El Gad
Senior Business Development Manager – Self Injection Systems
Europe and Asia Pacific
West Pharmaceutical Services, Inc.
15:15 – 16:00 Biological and Device Combination:
Living in Both Worlds
Roberto Meidler, PhD
Research Fellow, R&D, Omrix
16:00 – 16:30 Consideration in Development of Combination Products (Device with Drugs/Biologics) Sara Horn, Ph.D.
CEO, Sara Horn Ltd. - Regulatory and Clinical Consultancy Services
16:30 – 17:45 Questions & Answers

Note: the program and speakers are tentative and subject to change without prior notice.

Target Audience

Pharmaceutical and biopharmaceutical drug manufacturers that are producing medical device and drug combination products.

Participation Fees:
PDA members - 450 NIS
Non members - 550 NIS 

Become a member at the international PDA

 

Organized & Produced by
Bioforum - Applied Knowledge Center
Golda Meir 3, Weizmann Science Park
P.O.B. 4034 Ness Ziona, Israel, 70400
Tel: 08-9313070
Fax: 08-9313071
E-mail: bioforum@bioforum.co.il
site: www.bioforum.co.il