Everyone has been a patient at some point in time. Because we are all consumers of healthcare, keeping up with the latest regulatory issues in the pharmaceutical industry is not only important for our companies, but also for us as individuals.

The 2015 PDA/FDA Joint Regulatory Conference the theme of which is Mission Possible: Patient-Focused Manufacturing, Quality and Regulatory Solutions, will connect you with global regulators and a group of dedicated colleagues from around the world who are working hard every day to ensure patient safety.

The growing list of regulatory expert presenters includes:

• Thomas Cosgrove, Office Director, OMPQ, CDER, FDA
• Richard Friedman, Deputy Director, Science and Regulatory Policy, OMPQ, CDER, FDA
• Michael Havert, PhD, Gene Therapy Reviewer, Division of Cell and Gene Therapy, CBER, FDA
• Scott Macintire, Director, Division of Enforcement, OE, ORA, FDA
• Janet Woodcock, PhD, Director, CDER, FDA

Early conference risers, take your pick from a series of breakfast sessions, which provide a smaller group setting to facilitate in-depth discussion on regulatory “hot topics” such as:

• Quality Metrics/Quality Culture
• New Inspection Protocol Project (NIPP)
• ICH Q7 Q&A
• Human Factors
• Inspection Trends
• Legacy Biotech

To make this exceptional conference even more accessible and infinitely more valuable to our Japanese-speaking attendees, for the first time, PDA will offer simultaneous translation from Japanese to English and English to Japanese.

Attend the 2015 PDA/FDA Joint Regulatory Conference and develop a network of pharmaceutical colleagues to call when pressing questions arise outside of conferences. Register by Aug. 18 and save up to $200!

Want even more practical advice and implementable solutions? Extend your stay to attend the 2015 Manufacturing Science Workshop September 30-October 1 and the 2015 PDA Regulatory Conference Course Series October 1-2.

Parenteral Drug Association (PDA)
4350 East West Highway, Suite 150
Bethesda, MD 20814 USA
Tel: +1 (301) 656-5900
Fax: +1 (301) 986-1093
www.pda.org

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