Regulatory review and outlook for 2013 and beyond
28 February - 1 March 2013 in Mumbai, India
Come join us in Mumbai and expand your expertise pool!
The European and South Asian Regulatory systems can be confusing and complex particularly for those not based in these regions. Our two days seminar will provide a unique opportunity to pharmaceutical industry to review and interact with experts in the field. The purpose of this course is to provide you with a clear and concise understanding of the Regulatory environment in both the European Union and South Asia (Vietnam, Indonesia, China, Australia, etc.) including an overview of the key regulatory processes and procedures.
We will discuss:
- European Institutions and the European Legislative framework - Navigating European regulatory framework for active substance, drug product, variation regulation and pharmacovigilance legislations
- Regulatory Framework in Asia Pacific with Emphasis on ASEAN harmonization - Overcoming Regulatory complexities in ASEAN region
- European Clinical Trial Processes and Procedures (how to make your bioequivalence study be recognized by the EU Health Authorities)
- European Marketing Authorization Processes and Procedures, including the different models for price and reimbursement
- How to find business partners in the EU
- The European system for classification of Post Approval Amendments (Variations) and associated procedures
- How to manage your business in Europe and in Asia Pacific
- New EU PV guidelines- Challenges - Pharmacovigilance update including plans for 2013
This training course will provide a limited pool of attendees an excellent overview of latest changes in the European and South-Asian Regulatory procedures.
Regulatory strategy which impacts on commercial, business and licensing arrangements will be of importance to those responsible for business development.
In short, this will be a fantastic opportunity to meet the experts that you need today and to tap into the network of experts that you more than likely will need tomorrow.
Or you can also call your sales representative on +420 22 491 00 00 or + 91 79 4024 1999
We hope that this course is of interest to you, and look forward to welcoming you to an ELC GROUP training course soon.