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.

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.

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

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

Cheryl English
Steering Group Member

Joanna Gunston
Steering Group Member

Roy Jamieson
Steering Group Member

Michael Oguntusin
Steering Group Member

Matt Popkin
Steering Group Member

Walkiria Schlindwein
Steering Group Member

Focus Group Members

Rasha Alshaikh
Focus Group Member

Shakera Begum
Focus Group Member

Patel Foram
Focus Group Member

Dimitra Mitsa
Focus Group Member

Orla Ní Ógáin
Focus Group Member

Ouannassa Rached
Focus Group Member

Giovanna Ramalho
Focus Group Member