What We Do
Find out what has happened and the plans for the Focus Group.
We’ve developed and delivered the following successful 2-day residential courses since 2014:
- November 2015 – Regulatory Essentials with focus on the development and registration of oral dosage forms
- May 2016 – Excipients – selection, control, application and suitability (in collaboration with the Material Science Focus Group)
- 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:
- 2014: Process validation and continuous process verification – expectations and experiences
- 2015: Supporting innovation to improve patient access to safe and effective medicines
- 2015: Excipients – their selection, control and suitability (in collaboration with the Material Science Focus Group)
- 2016: Future directions in global regulatory harmonisation
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
Potential collaborations:
- Clinical relevant specifications and ICH M9 – BCS-based biowaivers (with Biopharmaceutics Focus Group)
- How to influence clinical practice/use of age-related medicines (with Age Related Medicines Focus Group)
- Fixed dose combinations (with Age Related Medicines Focus Group)
- Accelerating time to market continuous manufacturing (with Process Engineering and Formulation Focus Group)
- Regulation of biologicals/biosimilars as medicines (with Biotherapeutics and Vaccines Focus Group)
Future plans are under consideration.