Opening of meeting Copenhagen, Denmark September

Transcription

1 Opening of meeting 1

2 Objectives of the meeting 1. To bring together a wide range of stakeholders whose combined efforts bring needed health products to vulnerable populations. 2. To sustain partnership, stimulate new exchanges and promote new partnerships 3. Provide updates from the WHO, UNICEF and UNFPA to stakeholders 4. Obtain feedback from stakeholders on: a) areas where things are going on well to be sustained b) areas that require improvement c) new areas of focus and innovation in the next year 5. Discuss issues that influence manufacturers participation in PQ: a) markets and value proposition of prequalified products and necessary investments b) Price consideration, determinants, sustainability and impact 2

3 Outline of the programme Day 1: Monday 18 Sept 2017 Session 1: Opening of meeting Venue: In auditorium I, II & III merged Scope: Key messages from WHO, UNICEF and UNFPA Session 2: A review of the markets for qualityassured products Venue: In auditorium I, II & III merged Scope: markets; prices; managing supply and shortages Session 3: How manufacturers can assess the value of quality-assured products Venue: In auditorium I, II & III merged Scope: Value proposition; stimulating introduction of new products Reception for all participants: Lounge area 9 3

4 Day 2: Tuesday 19 Sept 2017 Session 4: Procurement updates (Auditorium III) IVD prequalification for new applicants (Auditorium II) Introduction to vector control prequalification (Auditorium II) UNFPA / WHO contraceptive devices prequalification (Press Room) Session 5: Procurement updates Introduction to vaccines prequalification for new applicants WHO/UNFPA prequalification technical updates by product track Introduction to who pilot prequalification of biosimilars for cancer treatment Inspection updates Updates on technical assistance Updates on cold chain Improving traceability One to one meetings with PQT, Procurement agencies, Technical assistance and WHO collaborative procedure 4

5 Day 3: Wednesday, 20 September 2017 Session 6: Investing in WHO prequalification Venue: In auditorium I, II & III merged Scope: Reducing prequalification cost and maximizing opportunities Session 7: Getting products to markets promptly WHO collaborative registration & Caribbean regulatory system Venue: In auditorium I, II & III merged: Session 8: Prequalification feedback: open forum Venue: In auditorium I, II & III merged: One to one meetings with PQT, Procurement agencies, UNFPA, WHO collaborative procedure and Caribbean regulatory system 5

6 Day 4: Continuation of One to one meetings with PQT, Procurement agencies, UNFPA, WHO collaborative procedure and Caribbean regulatory system 6

7 Profile of participants Stakeholders whose combined efforts bring needed health products to vulnerable populations: manufacturers quality, safety and efficacy experts procurement agencies; and international donors Over 400 registered participants representing nearly 60 countries from all WHO regions. The 2017 meeting will cover not only vitro diagnostic products (IVDs), vaccines, finished pharmaceutical products, active pharmaceutical ingredients, and contraceptive devices, but also vector control products. 7

8 Opening meeting SESSION 1 IN AUDITORIUM I, II & III merged: OPENING OF MEETING Welcome address Given by: Emer Cooke, Head, Regulation of Medicines and other Health Technologies (WHO), 08:45 09:00 Suvi Rautio, Deputy Director, Supply Programme (UNICEF Supply Division); Eric Dupont, Chief, Procurement Services Branch (UNFPA) Administrative/security arrangements Given by: Jesper Palm 09:00 09:10 Lundorf (UN Office of the Designated Official for Security) 09:10 09:20 Introduction to meeting outline and app Deus Mubangizi and Mercedes Pérez González (WHO) 8