Strategic Development

The Founders of the PIC Convention had a visionary idea - that of creating a free trade market for pharmaceutical products and facilitating the international trade while ensuring the best possible protection of patients through high GMP standards. This was to be achieved by the mutual recognition of GMP inspections - the PIC Convention - and the harmonisation of GMP standards - the PIC GMP Guide.

Mission & Goals 

In 1995, when the Convention’s successful expansion was stopped due to an alleged incompatibility with European law, the PIC Committee of Officials came with another visionary idea, which was to create a non-binding platform to exchange GMP-related information and to further harmonise GMP standards as well as provide GMP training. The PIC Scheme was born.

At its 65th meeting in Geneva on 22-23 April 2002, the PIC/S Committee adopted the following mission and goals for PIC/S:

“To lead the international development, implementation and maintenance of harmonised GMP standards and quality systems of inspectorates in the field of medicinal products”

This is to be achieved by:

  • Developing and promoting harmonised GMP standards and guidance documents;
  • Training competent authorities, in particular Inspectors;
  • Assessing (and reassessing) Inspectorates;
  • Facilitating the co-operation and networking for competent authorities and international organisations. 

By and large, the overall mission and the way the goals should be achieved are still valid today. But will it still be the case tomorrow? Visionary, strategic thinking has been the key of PIC/S success of the past 40 years. This is why strategic development is essential to guarantee PIC/S’ future.

History & Mandate

The Sub-Committee on Strategic Development (SCSD) was set up by the PIC/S Committee in 2009 in order to discuss, amongst other matters, the outcome of a survey on how to improve the operation of the Scheme. Following a suggestion by the Irish Medicines Board to establish more Sub-Committees under the PIC/S Committee, the SCSD elaborated a concrete proposal on how to set up and implement a Sub-Committee structure.

The SCSD’s primary mandate is to define PIC/S’ strategy and future policy and make proposals on how to improve the structure and the operation of PIC/S.

Since 2014, the SCSD is also in charge of making proposals on the possible “expansion” of PIC/S’ mandate to other areas, on discussing new projects and addressing their possible funding and also on how to improve co-operation with PIC/S Partner Organisations.

The SCSD is chaired by Mr Jacques Morénas (France / ANSM).

Since its creation, the SCSD has made a number of proposals to the PIC/S Committee - the most important being so far the introduction of a Sub-Committee structure, which was successfully implemented in 2014.

The full mandate of the SCSD is to:

 

  1. Define and review PIC/S strategy and (future) policy
  2. Make proposals / recommendations on how to improve the structure and the operation of PIC/S
  3. Ensure the implementation of strategical policies (e.g. roadmaps such as the Blueprint) as well as strategical decisions
  4. Discuss new projects for PIC/S and make proposals on the possible “expansion” of PIC/S’ mandate to other areas
  5. Address implementation of new projects and resource management - in particular funding (e.g. external) - in consultation with PIC/S PA and Heads of Agencies
  6. Review co-operation with Partners and make proposals / recommendations for the possible improvement of the co-operation
  7. Promote the participation of authorities interested in the PIC Scheme
  8. Report back to the PIC/S Committee, as provided for in the Terms of References and make proposals / recommendations