The conference will be the ideal place to hear the very latest thinking from the MHRA's senior experts and industry-leading speakers on topics including state-of-play and future trends for supporting science and innovation in the development and regulation of medicines; how the expanded MHRA remit can benefit its stakeholders; exploring regulatory flexibilities within existing EU legislation to stimulate innovation; and innovative approaches to pharmacovigilance and lifecycle management.
Confirmed speakers at the conference are:
• Sir Gordon Duff, Chairman of MHRA
• Dr Will Dere, International Chief Medical Officer and Senior Vice President, Global Development, Amgen
• Dr Stephen Inglis, Director of NIBSC
• Dr John Parkinson, Director of CPRD
• Fiona Reekie, Director of Regulatory Intelligence, Europe and Global Emerging Markets, Biogen Idec
• Dr Daniel O'Connor, Medical Assessor, Licensing Division, MHRA
• James Matcham, Director Biostatistics, Amgen
• Dr David Wright, Deputy Unit Manager, Licensing Division, MHRA
• Ian Rees, Expert GMP Inspector, MHRA
• Dr Philip Minor, NIBSC
• Dr Philip Bryan, Unit Manager, Vigilance and Risk Management of Medicines, MHRA
• Dr Dina Tresnan, Senior Director, Worldwide Safety Surveillance and Risk Management, Pfizer
• Dr David Gillen, Medical Director, Celgene
Dr Ian Hudson, MHRA, Director of Licensing, Vice-Chair of EMA's Committee for Medicinal Products for Human Use (CHMP) and conference co-chair, said:
"This is an excellent opportunity for the agency to share their knowledge and expertise at this one day conference on 5 June with the BioIndustry Association. We're looking forward to providing advice and assistance to people who are developing innovative products or exploring innovative approaches within the biopharmaceutical industry."
Alan Morrison, Vice President, International Regulatory Affairs and Safety, Amgen, Chairman of BIA's Regulatory Affairs Advisory Committee and conference co-chair, said:
"The event will build on the successes of the BIA's previous joint conferences with MHRA and provide an excellent opportunity for industry to learn about latest developments from the regulator and for the regulator to learn about advances in biopharmaceutical innovation from within the industry."
For further information, please contact:
BIA - Robert Winder, Head of Communications, rwinder@bioindustry.org, 020 7630 2191; mobile 07825 942 934.
MHRA - MHRA Press Office press.office@mhra.gsi.gov.uk 020 3080 7651
Joint BIA-MHRA conference
Joint BIA-MHRA Conference - Innovation in the development and regulation of biopharmaceuticals will be held on 5 June 2013 at the Wellcome Collection Conference Centre in London http://bit.ly/BIAMHRA2013 or http://bit.ly/MHRABIA_2013
Medicines and Healthcare Products Regulatory Agency
The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. Underpinning all our work lies robust and fact-based judgments to ensure that the benefits justify any risks. The MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC), (www.nibsc.org) and the Clinical Practice Research Datalink (CPRD). (www.cprd.com). The MHRA is an executive agency of the Department of Health. For more information please visit www.mhra.gov.uk
BioIndustry Association
Founded over 20 years ago at the infancy of biotechnology, the BioIndustry Association (BIA) is the trade association for innovative enterprises involved in UK bioscience. Members include emerging and more established bioscience companies; pharmaceutical companies; academic, research and philanthropic organisations; and service providers to the bioscience sector. The BIA represents the interests of its members to a broad section of stakeholders, from government and regulators to patient groups and the media. Our goal is to secure the UK's position as a global hub and as the best location for innovative research and commercialisation, enabling our world-leading research base to deliver healthcare solutions that can truly make a difference to people's lives. For further information, please go to www.bioindustry.org