Date: 27th February 2013
Cambridge, UK, 27th February 2013 – ELC GROUP, one of the fastest-growing providers of regulatory affairs consulting services, today announces that it will be hosting a two-day seminar from 13th – 14th March 2013 in Riga, Latvia. The exclusive training event – “Responsibilities of manufacturing authorisation holder (MAH) and release of pharmaceuticals in the EU and other regions” – is dedicated to marketing authorisation holders, pharmaceutical industry and regulatory affairs professionals. The training content will be delivered by two expert speakers from ELC Group, Parvinder Punia and Chetan Javia.
The two-day seminar, which is being organised by the Association of Latvian Chemical and Pharmaceutical Industry and hosted by ELC Group, will provide a unique opportunity for pharmaceutical industry professionals to learn about European licensing strategies, troubleshooting regulatory affairs (RA) problems in the EU, manufacturing and batch release requirements, and management of MAs in the EU region. Attendees will learn how to define an EU strategy budget, controls and risk mitigation methods, how to communicate with agencies and meet the requirements for licensing. Attendees will also learn manufacturing needs according to current guidelines, plus how strategies tie into lifecycle management.
With a decade of regulatory experience – including roles in two EU Health Agencies – Parvinder Punia is an RA expert in the EU and other regulated region procedures. Responsible for managing worldwide submissions, she has expertise in regulatory strategy development, budgeting preparation, and scientific and regulatory documentation. From dossier preparations and conversions for devices and medicines, she regularly employs her extensive working knowledge of European licensing procedures (Mutual Recognition and Decentralization). Her background includes working as a project manager at the UK Health Agency MHRA and INFARMED, the Portuguese Health Agency.
Chetan Javia is ELC Group’s regulatory affairs expert in India, and his team manages every aspect of the submissions process – from the development of a regulatory strategy to providing regulatory and scientific advice on applications for Europe and ‘rest of the world’ countries. A qualified pharmacist, he has extensive experience in overseeing new and re-registration submissions in variety of international geographies – including the Middle East and Central America.
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Note to editors:
If you would be interested in scheduling a briefing with ELC Group, please contact Nicky Denovan at nicky[at]evokedset[dot]com.
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:
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.