There was a full house for the tenth Medicines and Healthcare products Regulatory Agency (MHRA) Annual Lecture on Wednesday 25 March, delivered in central London by Dr Dan Hartman - Director of Integrated Development for the Bill and Melinda Gates Foundation, the leading philanthropy organisation set up by Bill and Melinda Gates.
Dr Hartman leads a team that provides technical expertise in drug and diagnostic development. Under his leadership, Integrated Development works closely with the foundation’s programme strategy teams to manage product pipelines through clinical trials as well as providing help with manufacturing, compliance and regulatory strategy/intelligence.
His speech was entitled: The Global Health Regulatory Environment, where are we, how can regulators in the developed world help, what can we learn?
It provided a fascinating ‘insider view’ about the aims of the Gates Foundation, how they face up to tough challenges in global health and development working with a network of partners to promote and improve public health in the developing world.
Dr Hartman gave an overview of the developing world health environment and current innovations to address related health challenges. He then compared the regulatory environments of developed and developing countries, highlighting recent progress to shorten the 4 to 7 year regulatory pathway in Sub-Saharan Africa to bring these innovations to the billions of patients and populations in need. Dr Hartman concluded with some ideas for what role developed world regulators such as MHRA can play in this important endeavor.
MHRA Chief Executive Dr Ian Hudson said:
This excellent lecture provided a fascinating insight into some of the health problems faced by developing countries, how regulatory capacity can be built and how developed counties can help.
Dr Hartman said:
It was a pleasure to share the challenges and more importantly progress our many partners have achieved in more rapidly bringing innovative and essential medicine to developing country populations we aim to serve.
The lecture was followed by a Q&A session and panel discussion involving Dr Hartman, Dr Ian Hudson, Dr June Raine, Vigilance and Risk Management of Medicines Director, MHRA, Gerald Heddell, Inspection, Enforcement and Standards Director, Janet Valentine, CPRD Director and was chaired by MHRA Chair, Sir Michael Rawlins.
MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare Products Regulatory Agency which also includes the NatioI startednal Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The MHRA is an executive agency of the Department of Health. www.gov.uk/mhra