Who we are

Regulatory Focus Group.

This Focus Group was formed to bridge the gap between the science and regulation of medicines, and to facilitate discussion and consideration of regulatory aspects relevant to the development of new and improved medicines. There is considerable overlap between the specialist scientific areas covered by APS Focus Groups and the key operations for which the MHRA has regulatory responsibility.

The focus group steering committee has representation from industrial scientists at Pfizer, GSK, AstraZeneca and Bristol-Myers Squibb, academics from the University of Bath and De Montfort University, a regulatory consultant in product development and regulators from the Licensing Division at the MHRA.

The Focus Group will promote awareness of regulatory requirements and deliver scientific education and training applied to the development and licensing of human medicines. The Focus Group will contribute to the scientific programme for the annual APS PharmSci conference and organise additional symposia to promote awareness of regulatory science.

The Regulatory Focus Group operates to provide support to the other Focus Groups through the development of collaborative programmes and to ensure that regulatory aspects are built into product development. In addition, the Regulatory Focus Group continues to develop and deliver its own agenda for the benefit of APS members.

I formed the Regulatory Focus Group in 2014 to bridge the gap between the science and regulation and to ensure that regulatory considerations were built into APS symposia and that Focus Groups had access to regulators and regulatory input. The current Steering Committee consists of: – Dawn Adkin, CMC Consultant – Alastair Coupe, Pfizer – Malcolm Dash, MHRA (Chair) – Begoña Delgado-Charro, University of Bath – Elspeth Gray, MHRA – Roy Jamieson, AstraZeneca – Matt Popkin, GSK – Colm Reddington, MHRA – Walkiria Schlindwein, De Montfort University, Leicester – Vicky Wright, Bristol-Myers Squibb.

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