Senior EDQM officials to address two-day seminar on Regulatory Submission Procedures in EU

In an effort to update the pharmaceutical industry in the country on Regulatory Submission Procedures in the European Union, a two day event highlighting the European Directorate on the Quality of Medicines (EDQM) is being held in Bangalore on November 13 and 14. The event is organized by Prescription Pharma Support, a premier service provider to the pharma and biotech industry. The theme of the event is Regulatory Submission Procedures in the EU: APIs and Drug Products. The EDQM is being represented by three of their senior officials. There will also be a special focus on GMP, European Pharmacopoeia. The senior members of EDQM who will be here for the seminar are Dr Claude Coune, head of the Publications & Multimedia EDQM), Dr Andrew Mcmath, scientific officer in the Certification of Substances Division, and Dr Pascale Poukens-Renwart, scientific officer in the Certification Unit and in-charge of Phytochemical Groups of Experts. This two-day symposium will give participants with the basic knowledge needed to understand the European regulatory environment. It will provide each participant with a comprehensive knowledge of the activities and missions of the EDQM. Participants will learn about the European Pharmacopoeia and how to use its monographs, and it will cover specific issues such as the test methods for impurities and polymorphism. The seminar will cover European Pharmacopoeia reference standards and discuss impurity standards. It will also provide the tools to professionals to understand CEP application and how to monitor and keep up-to-date with the continually changing regulatory landscape. It will cover subjects such as electronic submissions (eCTD), common deficiencies found in applications, the essential elements of a Quality Overall Summary, the procedures for renewal and variation of CEPs, the validity of CEPs and the EDQM's inspection programme. The seminar is targeting the personnel from the Senior Management, Regulatory Affairs, GMP Compliance, Quality Assurance, Product Development, manufacturing and pharma consultants.