Welcome to the Regulatory Focus Group
Who We Are
The Regulatory Focus Group was formed in 2014 and consists of a steering committee which currently has representation from industrial scientists at Pfizer, GSK, AstraZeneca, Jazz Pharmaceuticals and Bristol-Myers Squibb, academics from the De Montfort University, a regulatory consultant in product development and regulators from MHRA.
What We Do
The Focus Group promotes 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 events to promote awareness of regulatory science, both ourselves and in collaboration with other Focus Groups for the benefit of APS members.
What We’ve Done
We’ve developed and delivered the following successful 2-day residential courses since 2014:
- March 2018 – Current regulatory trends & updates in parenteral drug product development (in collaboration with the Parenterals Focus Group)
- May 2018 – Regulatory Essentials II: The development and registration of oral dosage forms
The Regulatory Focus Group was also instrumental in the development of the APS programme (through proposals made by a Regulatory Focus Group Steering Committee member) for the following 1-day symposium:
- March 2018 – Accelerating paediatric formulation development (presentation output from SPaeDD-UK Project)
The Regulatory Focus Group has also developed and run the following science sessions at APS PharmSci conferences:
- 2016: Future directions in global regulatory harmonisation
- 2023: Steering Innovative products through the regulatory landscape Hot Scientific Topics
- 2024: Regulatory Focus Group – Vision of the Future to enable Innovation & Patient Access
Hot Scientific Topics
The following hot topics and potential areas of collaboration are of current interest to the Focus Group:
- Innovative manufacturing platforms/processes
- Biologicals – new modalities
- Dosage form design – supporting successful registration
- Accelerating time to market – focus on regulatory goals
- Regulatory Reliance
- Revisions to ICH Quality Guidance
- Clinical relevant specifications
Meet The Group
Focus Group Leaders
Focus Group Members
why you should get involved…
Our vision is for the Focus Group to be a vibrant discussion forum for regulatory topics. We are
planning to run individual and collaborative meetings with other APS Focus Groups as well as
dedicated regulatory programmes. We are seeking to expand the Focus group membership and
welcome new members from across the academic, industry and regulatory agency field. Our goal is
that the Focus Group membership will propose events, contribute to their organisation and
volunteer for relevant speaking opportunities. If you want to learn more, please join today!