PDA one day seminar: The new EU Risk Assessment approach

Hours: 14:00-17:30
Registration: 13:30-14:00
SKU: P16737
Organized by: Mr. Frithjof Holtz

The European directive 2011/62/EU, known as the “Falsified Medicine Directive” states that the pharmaceutical manufacturer has to perform a formalized risk assessment and has to verify the appropriate GMP for excipients. This also applies to companies outside the EU, selling products to the EU. In March 2015 the EU Commission published the "Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (2015/C 95/02)". With this presentation insights in the EU Commission’s risk assessment approach to excipient quality will be provided.
Furthermore you will learn about the most recent regulatory trends on pharmaceutical excipients and best practices how pharmaceutical companies can identify suitable materials used in the manufacturing process.

Seminar program:

13:30-14:00	Registration
14:00-14:30	Elemental Impurities: ICH Q3D finalized
14:30-14:45	Q&A
14:45-15:15	GDP for pharmaceutical excipients
15:15-15:30	Q&A
15:30-16:00	Coffee break
16:00-16:30	New EU regulations on GMP for pharmaceutical excipients
16:30-16:45	Q&A
16:45-17:15	EXCiPACT: A pharmaceutical excipients certification scheme
17:15-17:30	Q&A

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

Lecturer:

Mr. Frithjof Holtz
Mr. Frithjof Holtz is a biologist and has been working for more than 25 years with Merck KGaA, Darmstadt, Germany, having years of experience in quality assurance and regulatory affairs. As Head of Advocacy / Surveillance he has the global responsibility for the regulatory surveillance and the advocacy activities of the Merck division, Merck Life Science. Frithjof Holtz is an active member of several international industry associations and industry initiatives as PDA, APIC, Rx-360 and EXCiPACTTM, and member of the board of IPEC Europe, EFCG.

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