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.

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