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Cambridge, UK, December 7th 2011 – ELC GROUP, the pan-European pharmaceutical regulatory affairs organisation, today announces that it will be hosting an international training seminar on 23rd February 2012 in Ahmedabad, India. The event will address the regulatory challenges for 2012 and their impact on marketing authorisation.
As well as an overview of the latest changes in European Regulatory Procedures, the day will focus on the implementation of electronic submission of medical production information in the new EU requirements of the Pharmacovigilance legislation.
The full-day course will cover the evolution of the registration systems available for approval of products in the EU, together with major changes in New Medicines Legislation. These changes include regulatory procedures, access to Centralised and Mutual Recognition Procedures and reduction in Regulatory Data protection.
There will also be discussion on regulatory strategy which impacts on commercial, business and licensing arrangements and will be of importance to those responsible for business development.
ELC GROUP’s Advisory Board member, Dr. Paolo Biffignandi MD, PhD, QPPV, FTOPRA, will host the day. Dr. Biffignandi has over 30 years’ experience in Regulatory Affairs and pharmacovigilance. He is a past President and now Fellow of The Organisation for Professionals in Regulatory Affairs (TOPRA) and a renowned physician, with PhDs in endocrinology and pharmacology. He is also an Overseas Fellow of the Royal Society of Medicine (UK) and provides a regulatory column for EPM magazine (European Pharmaceutical Manufacturer).
Speaking about seminar, Marco Rubinstein ELC GROUP CEO said: “We are delighted to be hosting this event and sharing Paolo’s expert knowledge with an ever increasing audience. This event will be a fantastic opportunity for attendees to meet experts in the complex field of EU Pharma regulation.”