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ELC Group shared the very latest developments in regulatory affairs with delegates at its successful International Regulatory Seminar in Ahmedabad, India on February 23rd 2012. The full-day training event was hosted by Past President of TOPRA and ELC Group Advisor Dr. Paolo Biffignandi (MD, PhD, QPPV, FTOPRA) and addressed regulatory challenges for 2012 and their impact on marketing authorisation.
Delegates from nearly 20 global companies attended the event, ranging from general managers and heads of regulatory affairs, business development & strategic planning, clinical affairs heads and senior managers of drug regulation. ELC Group experts including Dr. Biffignandi and Parvinder Punia, Senior Manager of Regulatory Affairs, provided the audience with a wide-ranging overview of the latest changes in European Regulatory Procedures, including a key focus on EVMPD implementation and how to address the challenge of meeting the 2nd July 2012 EMA deadline for electronic submission of medical production information under the new EU pharmacovigilance legislation.
Additional presentation topics on the day included the evolution of registration systems available for approval of products in the EU, together with major changes in New Medicines Legislation, covering regulatory procedures, access to Centralised and Mutual Recognition Procedures and reduction in Regulatory Data protection. Delegates had the opportunity to discuss regulatory strategy and its impact on commercial, business and licensing arrangements – of particular importance to those attendees with key responsibility for business development.
Mumbai-based healthcare supplier Famy Care Ltd rounded off the event with a well-received sponsored Tea Party for delegates. The feedback from attendees was excellent and ELC Group has plans to repeat this valuable forum in Mumbai – the world’s largest pharmaceutical hub and home to over 25 global headquarters of ELC Group clients.