Web Code: PDAFDAC311
Member/Nonmember Price: $75
On January 1, 2011, FDA joined the Pharmaceutical Inspection Co-operation Scheme (PIC/S). PIC/S, based out of Geneva, is an international organization for pharmaceutical inspectorates which fosters cooperation in development, training and interpretation of pharmaceutical Good Manufacturing Practices (GMP). PIC/S promotes harmonized GMP standards and guidance’s and has a program for assessing the inspectorates of member countries. In recent years, significant changes to GMP have been developed thru PIC/S initiatives (e.g. ICH Q7a) and it is anticipated that the membership of FDA will strengthen this role. This seminar will provide an overview of FDA's perspectives on membership in PIC/S, including FDA goals and next steps in collaboration. In addition, there will be an industry perspective on possible benefits and opportunities as a result of the 'new' PIC/S.
Research & Development | Regulatory Affairs | Manufacturing | Quality Assurance/Control | Marketing | Sales
Supply Chain | Clinical Supply Material Preparation | Executive Management
Stephan Roenninger, PhD, Head of External Relations Europe/Japan, F. Hoffmann-La Roche Ltd
Dr. Stephan Rönninger is the ‘Head of External Relations Europe / Japan’ of F. Hoffmann-La Roche Ltd based in Basel, Switzerland and also responsible for collaboration, information management and commenting regarding Quality Management, Good Manufacturing and Distribution Practice (GMDP) topics.
He represents on behalf of Roche in the European industry association EFPIA and is acting as moderator of the network on "Better Regulations” including foreign regulatory GMP/GDP inspections and represents EFPIA in the ICH Quality Implementation Working Group (Q-IWG), on Quality Risk Management (ICH Q9) and as GMP expert in the discussions regarding GMP-certificates for Turkey.
In the Parenteral Drug Association (PDA) he acts as chair and the European Regional Leader in the Regulatory Affairs and Quality Advisory Board (RAQAB). He is one of the founders and co-chair of the ‘Paradigm Change in Manufacturing Operations’ (PCMO).
Brenda Holman, Executive Director, ORA Strategic Initiatives, ORA, FDA
Brenda Holman has been with FDA twenty three years. She holds a Bachelor of Science degree in Microbiology and a Master of Science degree in Food Science and Technology. She started with FDA in the Northeast Region as a Milk and Food Program Specialist, then as a Training Officer in State Training Branch in Rockville, Maryland, Assistant Regional Director responsible for State Cooperative Programs in the Pacific Region, District Director in Detroit District, District Director in New York District, Regional Food and Drug Director in the Pacific Region and currently the Executive Director of ORA Strategic Initiatives. In this capacity she is overseeing the implementation of an all inclusive Quality Management System in ORA. Her previous work experience includes seven years in state and local health departments in Texas, four years in industry quality assurance and two years as a food industry consultant. In August 2009 and August 2010, RADM Holman was actively involved in the PIC/S assessment of FDA as part of the Agency’s application for membership to PIC/S. FDA was officially accepted into PIC/S January 1, 2011 as a full Participating Authority.
Katrin Nodop, 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.
Jason E. Brown
Senior Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093