Venue: Hotel Courtyard Marriott, Mumbai, India
Working language: English
The global pharmaceutical industry has undergone profound transformations in recent years with the use of ever more sophisticated techniques and methods, and more complex supply chains due to international mergers and collaborations. The Indian pharmaceutical industry has also evolved to become one of the global leaders in providing high quality generics to the world.
This symposium is designed to provide and share knowledge of pharmaceutical legislation and the regulatory requirements that exist in Europe and India. It will explain in detail EDQM and IPC policies and procedures and give practical advice on how to comply with medicines regulations.
The programme covers:
- An overview of the roles of the EDQM/European Pharmacopoeia (Ph. Eur.) and the Indian Pharmacopoeia Commission (IPC) in the quality control of medicines including harmonisation activities;
- Practical advice on using and interpreting the European Pharmacopoeia General Chapters and Monographs;
- An outline of how European Pharmacopoeia monographs are elaborated and revised and of how to participate in this process;
- A closer look at impurities control and monographs for herbals and herbal preparations;
- An outline of the policies and processes used to establish Pharmaceutical Reference Standards;
- An overview of the regulatory requirements of the Procedure for Certification of Suitability to the Monographs of the European Pharmacopoeia, and guidance and advice on preparing a successful dossier; and
- An update on the Indian experience with Written confirmation Certification for API Exports to the EU.
Download the Draft Programme (subject to change)
Who should attend?
This symposium is of interest to authorities and manufacturers; all persons involved in the manufacture of APIs, from production, quality control and regulatory affairs.