‘Annual GPR Conference – 2013 Global Pharma Regulatory & Quality Compliance in Today’s Regulatory Enforcement Environment’ will be held in Mumbai on October 17 and 18. The theme is inspired by recent regulatory actions (483’s, Warning Letters, etc.) being issued to various global pharmaceutical companies. The backbone of the conference is based on the learning for conference attendees about: quality foundations, quality compliance and innovation, regulatory science. Individual sessions will be conducted on foreign inspections, recognised standards have been planned.
Dr Ajaz Hussain, ex US-FDA Deputy Commissioner, US will be addressing the conference on ‘Data Integrity Concerns.’ On the first day discussions will be held on some of the new global compliance initiatives and includes sessions on new regulations, good inspection practices, and an international update from the FDA perspective. An international udpate from regulatory perspective will include US/ Japan and the EU. The Innovation/ Regulatory Science will focus ICH Q11 and will have a discussion on GMP requirements.
On the second day of the conference, participants will learn about various issues related to quality management specifically pertaining to data integrity management issues in QC Lab, stability areas and how to handle and comply with the regulatory requirements. Individual sessions will discuss on foreign inspections, first cycle review, recognised standards in addition to a breakfast session titled ‘Discuss with the regulator: Regulatory & Quality Compliance.’
Speakers who will attend the event are Dr Ajaz Hussain, Ex US-FDA Deputy Commissioner, US; Ranjit Barshikar, QbD / cGMP Consultant; Zoher T Sihorwala, VP Global Regulatory, Dr Reddy’s Laboratory; Aparna Parinam, Associate Director – Regulatory Affairs, TEVA Pharmaceuticals Ind, Sanjay Jain, VP Quality Management, Amneal Pharma, Dr Deepak Haldankar, VP CQA, Sun Pharmaceutical Industries; Dr PV Kanitkar, Dir Operations, Pfizer India; Dale M Adkisson, Executive Vice President and Head Global Quality, Ranbaxy Laboratories; Hemant Narvekar, Head QA – CIPLA; Mahesh Zagade, India FDA – Commissioner Maharashtra FDA; Dr Nata Menabde, Head, WHO India; Dr Sanjay Shetgar – VP Quality / Head Global Generics – Dr Reddys Lab; Manu Grover, Asst Product Manager, Waters India; Shaun Quinn, Chromeleon Software Product Specialist Networking & Compliance, Thermo Scientific; Saroj Patnaik, Global Director – Emerson Life Sciences, Emerson Process Management and Sridhar Balasubramanian, HD and Director Global Development, QA, Novartis India.
EP News Bureau – Mumbai
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