1. Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 2007 1 |1 | Prequalification programme: Priority essential medicines Training Workshop on Pharmaceutical development with a Focus on Paediatric Medicines: Capacity building components of prequalification programme Milan Smid, QualityAssurance and Safety: Medicines, WHO smidm@who.int Tallinn, Estonia, 15 – 19 October 2007

2. Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 2007 2 |2 | Capacity building = support in development of expertise for development, manufacture, control or regulation of pharmaceutical products = integral component of Prequalification Programme

3. Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 2007 3 |3 | Capacity building = support to Manufacturers CROs Regulators Quality control laboratories

4. Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 2007 4 |4 | Capacity building Activities: Trainings Assistance Provision of information and standards

5. Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 2007 5 |5 | Trainings Seminars and workshops –general – information about PQ procedures, requirements and activities of WHO –problem oriented HIV/AIDS, TB and antimalarial products, pediatric dosage forms, BE, BE/BCS –facilitation of participation at trainings organised by third parties (EDQM) –trainings of NRA staff and manufacturers frequently combined

6. Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 2007 6 |6 | Trainings Involvement of assessors from NRAs in PQ assessment (Meetings in Copenhagen) Involvement of inspectors from NRAs in PQ inspections Rotations of experts from NRAs in WHO HQ –3 months working experience inside PQ team –previous understanding to WHO standards necessary –co-operation after the stay expected

7. Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 2007 7 |7 | Rotation positions - objectives (1) Strengthen national regulatory capacity by provision of training and personal development to experts from NMRAs Strengthen the confidence into PQP and evaluation of prequalified products by provision of deep insight into prequalification processes and expertise Disseminate understanding of PQP and strengthen Prequalification network by training of local and regional resource persons to be involved in Prequalification networking and trainings

8. Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 2007 8 |8 | Rotation positions - objectives (2) Identify new contributors to PQP from wide spectrum of Member States, especially from those Member States that are using or producing Prequalified products Strengthen PQP by trainees who may temporarily contribute to Prequalification expertise and who may provide unbiased view on Prequalification processes and documents Motivate and stimulate NRAs and trainees to commit themselves to future co-operation with PQP and initiate such co-operation

9. Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 2007 9 |9 | Assistance Expert advisors providing consultancy if relevant for PQ programme to –Manufacturers –Quality control laboratories –Regulators Assistance focuses on –GMP, GCP or GLP compliance –Regulatory guidance Assistance is separated from the assessment / inspections Assistance may be followed by specific trainings

10. Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 2007 10 | Provision of information Information related to individual PQ products –Product list and pending procedures –Public assessment reports (WHOPAR, SPC, PIL) –Public inspection reports (WHOPIR – APIs and FPPs) Development of guidelines and standards Published training materials / CDs http://who.int/prequal –PQ medicines and laboratories, guidelines, training materials Technical Briefing Seminar (Geneve, 26.Nov–1.Dec 2007)

11. Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 2007 11 |

12. Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 2007 12 | Provision of regulatory expertise Outcomes of WHO Prequalification may serve other regulators and manufacturers –WHOPARs –WHOPIRs Potential benefit –Reference assessment –Learning –Savings of expert capacity Considered - specific seminars for regulators on PQ medicines submitted for national authorizations

13. Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 2007 13 | Strategies used by regulators to cope with limited resources Concentration on priority issues most relevant for public health Improved effectivity of work Co-operation with partners and work-sharing –Facilitated by common standards and administrative requirements

14. Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 2007 14 | Use of expertise is not equal to recognition of decision Use of expertise Acceptance of decision –is formal legal act, frequently requiring international treaties –may modify liabilities of involved parties and requires legal specification of acceptance and non-acceptance Use of expertise –is sovereign and complex regulatory decision of NRA –acceptance of expertise may be based on scientific arguments and confidence –may be applied case to case –is followed by formal independent decision according to national legislation and mandate of NRA

15. Training Workshop on Pharmaceutical Development with a Focus on Paediatric Medicines / 15-19 October 2007 15 | Examples of sharing of regulatory expertise or development of common expertise WHO – standards, international expert teams, pharmacovigilance UMC, PQP ICH – common standards for developed markets, involvement of regulators as well as industry experts EU – coordination of expertise available to EU/EEA Member States by EMEA and EDQM, common EU procedures and sharing of expertise, Art. 58 procedures Australia and New Zealand – merger of NRAs Monaco, Liechtenstein – recognition of regulatory decisions of France, resp. Switzerland FDA, EMEA, WHO, TGA … etc. – MoU on sharing of information Canada, Switzerland, Japan, EU etc. – MRA on mutual acceptance of GMP standards PIC/S – share of standards and expertise on GMP, trainings, building confidence PER (in the past) – sharing of assessment reports among NRAs Regional and subregional initiatives – different extent of co-operation