LifeSciences BC's Industry Roundtable Discusses the Latest on EU Pharma Regulatory Regimes

April 21, 2009

LifeSciences BC and Topra were pleased to present a workshop on European and Canadian regulatory requirements for pharmaceutical clinical trials. Senior executives from EU health authorities and Health Canada provided an overview of the procedures for obtaining regulatory approval for clinical trials in their jurisdictions and discussed current and upcoming issues and amendments to clinical trials regulations.

They mentioned how the Canadian system is significantly different from the US IND system, and has more in common with the EU provisions; accordingly, an overview of the Canadian requirements was provided.

Our European speaker also provided insight into the latest proposals for new pharmaceutical legislation in Europe, as well as reviewed recent changes that have significantly altered the European regulatory arena for running clinical trials. These included the December 2008 “Pharmaceutical Package” of new legislation.

Following the presentations, an expert panel further discussed these issues and answered questions on regulatory aspects of running clinical trials in Europe or Canada.

Hosts

Topra (www.topra.org) is a global organisation for Regulatory Affairs professionals and for those who have an interest in Regulatory Affairs in the healthcare sector. Topra is a non-profit, non-political organisation which seeks to advance the status of the regulatory profession through education and provision of information.

LifeSciences BC represents the biopharmaceutical, medical device, bioproducts, bioenergy and greater life sciences community of British Columbia (www.lifesciencesbc.ca)

Biographies

Professor Tamás Paál – Professor Paál was previously the Director-general of the Hungarian medicines regulatory agency, the National Institute of Pharmacy. He retired from this position in April 2008, and took up the role of President of the Operative Board to the Director-General, appointed by the Health Minister. Professor Paál is, a member of TOPRA, DIA and EFGCP and many other organizations, as well as holder of awards of RAPS, DIA and TOPRA. He has published more than 160 papers on medicine evaluation, analysis as well as on Bood Practices.

Dr. Norman Viner – Dr Viner is Chief of the Clinical Trials Division, Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics (CERB) in the Biologic and Genetic Therapies Directorate (BGTD) of Health Canada, where he manages a team of reviewers who are responsible for reviewing the clinical aspects of the applications made to the Centre. This includes the applications involving Biotherapeutic Products, Therapeutic Vaccines, Gene Therapies and Radiopharmaceuticals. These reviews utilize the principles of risk benefit analysis in applying the Canadian Food and Drug Regulations to the clinical trial applications which fall under the jurisdiction of this directorate.

Aman Khera - Aman Khera (BSc. Hons in Medical Biochemistry from the UK) has nearly twelve years experience in Global Regulatory Affairs in the CRO industry. Coming from the UK over 3 years ago and having relocated to BC, she has extensive experience in managing the regulatory aspects of international clinical trials of investigational and marketed products, in addition to providing a broad range of regulatory services and consultancy. Aman has worked on a wide variety of projects including marketing authorization applications, as well as clinical trial notifications and applications worldwide and is currently at PRA International. She is a member of the TOPRA North American Leadership team.

Dawn Spark - Dawn has worked in the European regulatory affairs arena, in both pharmaceutical companies and in a CRO/consultancy environment, and has experience of dealing with pharmaceuticals, medical devices, food, cosmetics and borderline products.  Dawn is currently an employee of Fulcrum Pharma and her responsibilities include managing clinical trial applications (Phase I-IV) and Marketing Authorizations (Marketing Authorization Applications and post-marketing activities, such as variations, renewals, labeling and advertising).  Dawn has attended meetings with European regulatory authorities, including the MHRA and the EMEA, and has organized various training events and given presentations on different aspects of regulatory affairs.  Dawn is from the UK and moved to Vancouver in 2007, where she remains responsible for providing strategic advice on aspects of European regulatory affairs. Dawn is a member of the TOPRA North American Leadership team and Lifesciences BC.