Pharmaceutical and biologics manufacturing is vastly different today from what was “current” at the first GMP by the Sea conference. Globalization, automation, analytical technology and biopharmaceutical processes make compliance with GMPs much more complex. FDA and foreign counterpart agencies are aggressively enforcing their requirements.

This year’s GMP By The Sea conference is covering all of these issues. The plenary sessions, starting with a keynote by FDA Deputy Commissioner for International and Special Programs, Dr. Murray Lumpkin, will provide background on FDA’s new global perspective and information about operating and planned offices overseas.

* Gerald Heddell from the MHRA has been confirmed in place of Andrew Hopkins.  Mr. Heddell is the Director of Inspection, Enforcement & Standards.  His responsibilities focus on the quality of medicines in the UK and include a comprehensive surveillance, inspection and enforcement programme, the licensing of pharmaceutical manufacturers and wholesalers, defective medicines reporting, unlicensed imports, borderline products, medicines testing and the British Pharmacopoeia.