Global pharmaceutical regulatory affairs specialist ELC Group hosts International Training Seminar in Mumbai, India

Unique two-day training event will deliver expert updates on latest European and South Asian regulatory landscape

Cambridge, UK, 10th January 2013 – ELC GROUP, one of the fastest-growing providers of regulatory affairs consulting services, today announces that it will be hosting a two-day international training seminar from 28th February – 1st March 2013 in Mumbai, India. The unique training event, which will span all aspects of European and South Asian Regulatory systems, follows the success last year of ELC Group’s international regulatory seminar held in Ahmedabad, India.

The two-day seminar will provide a unique opportunity for pharmaceutical industry professionals to review the current international regulatory landscape and interact with experts in the field. The purpose of the course is to provide attendees with a clear and concise understanding of the regulatory environment in both the European Union and South Asia markets (including Vietnam, Indonesia, China and Australia).

The training content will deliver a comprehensive overview of the key regulatory processes and procedures in these major markets, with a specific focus on the following key areas:

• European Institutions and the European Legislative framework
• Regulatory Framework in Asia Pacific with Emphasis on ASEAN harmonisation
• European Clinical Trial Processes and Procedures (how to ensure bioequivalence studies are recognised by the EU Health Authorities)
• European Marketing Authorisation 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 and challenges – Pharmacovigilance update including plans for 2013

Attendance is encouraged from pharmaceutical industry and regulatory affairs professionals, plus business development executives interested in the impact of regulatory strategy on commercial, business and licensing arrangements.