5 day Workshop on International Drug Regulatory Affairs
Objectives
This classroom taught programme provides a practical insight into the international regulatory framework while learning from the experts. The workshop is designed to provide an insight into of the regulatory environment in advanced markets and will provide training in:
- How individual countries interact: US & Europe
- How regulations effect product development strategies
- Have the ability to write DMF's in the new format
- How to keep the DMF up to date
- Pricing issues - Coordinated filing vs. Individual filing
- Information necessary for effective submissions
- Strategies for streamlining the registration application process for faster approval
- The advantages and disadvantages for various registration procedures
- How to handle inspections and compliance
Methodology-
The program will include a mix of lectures, case studies, research work, group work and class assignments. The faculty bring with them vast knowledge, real-life experiences which would help participants get a feel of the issues at hand in the industry. Exercises, simulations, cases and conceptual models all help participants become more effective both as team members and as leaders. It moves away from typical classroom learning to intellectual stimulation and interactive learning. Participants will undertake exercises for regulatory submissions and writing a model DMF.
What can be achieved ?
The workshop will
- provide a clear understanding of the regulatory structure and ensure that the submissions meet the standards required by the regulators.
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focus on understanding the legal and regulatory environment, the registration procedures that are available, and the structure of the registration dossier.
- adopt a practical and interactive approach that will enable the participants to apply what they have learned to their daily regulatory work.
Fees : Early bird fee: RS. 25, 000/- for registration and cheques received before March 31, 2005.
Rs. 30,000/- for registration and cheques received after March 31, 2005
Registration:
- Will be limited to 25 participants
- Will be on first-come-first served basis
Who can benefit?
Compliance Managers, Documentation Managers, Products Registration Personnel, Product Managers in Regulatory Affairs, Marketing Managers, Clinical Research Personnel, Quality Control Personnel
Faculty
AIPS has a faculty of expert trainers who have up-to-date and practical knowledge of the pharmaceutical industry gained from first hand experience. They are professionals who are leaders in their field with a rich experience of more than a decade.
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5 day Workshop on International Drug Regulatory Affairs
