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.

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
  • 2023: Steering Innovative products through the regulatory landscape 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

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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