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.
Attendees can register to attend online at http://www.elc-group.com/content/events.php. Special early bird discounts are available for registrations completed by January 31st 2013.
ajain [at] elc-group [dot] com
Phone: +420 22 491 00 00
nicky[at] evokedset [dot] com
Phone: +44 (0)7747 017654
About ELC Group:(www.elc-group.com)
ELC GROUP is a full-service global provider of regulatory affairs consultancy. ELC GROUP delivers a complete service solution covering all aspects of Regulatory Affairs for medicinal products, medical devices, cosmetics, food supplements and foods for special medicinal purposes. ELC GROUP also provides specialist REACH regulatory services to the Chemical industry and Corporate Language solutions for Automotive, Chemical and Defense industries.
ELC GROUP’s worldwide network of professionals spans all major Regulatory Affairs services across the key healthcare vertical markets of Pharmaceuticals, Biotech, Clinical, Consumer Healthcare, Medical Devices, Nutraceuticals and Veterinary. The team ranges from former FDA investigators to individuals with over 30 years of industry experience and broad capabilities, including in the areas of integrated advanced technologies, Regulatory Affairs consulting and commercialisation services.
ELC GROUP works with equal success in partnership with large multi-nationals, small enterprises and start-ups, biotechs, CROs and device manufacturers.