2011 PDA/FDA Joint Regularty Conference – C1- Update on GMP and Quality Guidance

Web Code: PDAFDAC111
Member/Nonmember Price: $75

Seminar Summary

As our molecules and supply chains become more complex, global regulations are changing, and rapidly, to provide direction regarding regulatory expectations.  Regulators will discuss recently issued  regulations and guidelines from around the globe, including highlights on major changes.

Who Should Attend

Research & Development | Regulatory Affairs | Manufacturing | Quality Assurance/Control | Marketing | Sales

Job Functions
Supply Chain | Clinical Supply Material Preparation | Executive Management

Presenters Bio

Katrin Nodop, PhD, Head of Sector Support, Sector Compliance and Inspector Section, EMA

Katrin joined the Compliance and Inspection Sector at the European Medicines Agency in 1997.  She was responsible for the implementation and operational aspects of Mutual Recognition Agreements between the European Union and Third Countries including related activities; Sampling and Testing of Centrally Authorised Products; and she provided the secretariat for the EEA Joint Audit Programme of GMP inspectorates until very recently. Now Katrin focusses on the coordination of the implementation of the new European legislation on falsified medicines within the Agency and with the EU member states. She holds the chair of the EU GDP drafting group revising the EU GDP guideline and related procedures and the chair of the anti-falsification taskforce at the Agency. She also supports the Agency's GMDP Inspectors Working Group in regulatory GMP and GDP topics.

Katrin studied physics at the University München and graduated at Frankfurt University in February 1990. She has held a number of appointments in environmental research working in several European countries and international organisations before joining the EMA.

Brian Hasselbalch, Consumer Safety Officer, CDER, FDA

Mr. Hasselbalch has been with FDA for 21 years.  He began his service with FDA as an investigator and was performed primarily drug process inspections and related investigations in California and overseas.   Mr. Hasselbalch transferred to a compliance officer position in FDA’s Center for Drug Evaluation and Research in the mid-1990s, where he reviewed regulatory cases in the area of drug CGMPs, drafted guidance, policy, and regulations defining CGMP for drugs.  Mr. Hasselbalch is now the acting Associate Director for Policy and Communications in CDER’s Office of Compliance, Office of Manufacturing and Product Quality

Registration contact

Jason E. Brown
Senior Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093
Email: brown@pda.org