15th ANNUAL GENERAL MEETING 27‐29th October 2014 – New Delhi VACCINES, OUR SHARED RESPONSIBILITY DCVMN International Annual General Meeting – New Delhi, India Scientific Sessions Proposed Agenda 27 October
Time 8.30 am – 12.30 pm
2‐5 pm 2 pm
3 pm
4 pm
5 pm 27 Oct.
3 to 5 pm
6.30 – 7.30 pm Technology Symposium Speaker
Chair/ Co‐chair Steering Committee meeting on DCVMN new initiatives
Venue: Regency III Room New technologies for vaccine manufacturing & supply
S. Prasad/ M. Rush Venue : Crystal Ball Room( I‐II) Strategic Considerations for Implementation of Single Use P. Pattnaik
Technologies MerckMillipore Innovations in Temperature Monitoring: VVMs and T.Prussik
Beyond Temptime Corp. Practical Aspect in Designing Process Scale‐up
M. Payne
MerckMillipore Adjourn
DCVMN Executive Committee meeting
Venue : Regency III Room 1. Interim Annual report of activities and , discussion
Chair Mr. M. Suhardono 2. membership and partnerships, Co‐chair Dr. Harsha 3. budget 2015, EC Members only 4. GAVI & PPC report Welcome reception ‐ Alfresco All
28 Oct. Time Inaugural Session 8 :30 h 8 :45 h 9 :00 h 9:15 h Session 1 9 :30 h 9 :40 h 10:00 h 10 :20 h 10 :40 h Session 2 11 :00 h Topic
Venue : Crystal Ball Room (I‐II)
Global Public Health Needs of developing countries Opening & Introduction
Speaker
(* not yet confirmed) Chair/Co‐chair/Rapporteur
R. Jain/ M. Suhardono Mr. M. Suhardono
DCVMN President Welcome Note by the Host
Dr. R. Jain
Panacea Biotec Inaugural Address
Dr. Vijay Raghavan Secretary of Department of Biotechnology of the Ministry of Science & Technology, Government of India Polio eradication in India
Dr. Sunil Bahl
NPSP, WHO ‐ India Key Note Lectures
Key Note Address
Dr. R. Modi
Chair National Committee on Drugs and Pharmaceutical Global vaccine action: immunization and measles Dr. A. B. Thapa
elimination in SEA WHO SEARO representative Quality of vaccines: past, present and future
Dr. M P Kieny
WHO BMGF new collaborations and partnerships:
Dr. O. Levine
Linking development and delivery of vaccines BMGF Coffee break
Global Vaccine Procurement and Financing
Chair/Co‐chair/Rapporteur
Mr. A. Poonawalla*, Dr. O. Levine UNICEF procurement updates Dr. D. Mulenga
11 :20 h PAHO revolving fund updates 11 :40 h GAVI new initiatives for improving vaccine supply
12 :00 h Emergency vaccines: stockpiling and preparedness approaches Introduction to the Global Health Investment Fund 12 :20 h 12: 45 h Session 3 14 :00 h 14 :25 h 14 :45 h 15 :00 h 15 :15 h 15:30 h 16: 00 h 16 : 45 h 17 :30 h 19 :00 h UNICEF
Ms. M.Pereira
PAHO Ms. A. Nguyen
GAVI Dr. J. Schafer
HHS Mr. C.E. Warburton
GHIF Lunch break
Regulatory Science & Vaccines Chair/Co‐chair/Rapporteur
Mr. Ray Prasad/Dr. Dellepiane/P. Tippoo International regulatory collaborations
Dr. G.N. Singh
DCGI Strengthening developing countries’ regulatory Dr. N. Dellepiane
pathways WHO Presubmission dialogue between regulators and Dr. S. Inglis
manufacturers – a European perspective NIBSC Industry and regulatory bodies communication Dr. L. Slamet
beyond regulatory dossiers Regulatory Expert Communication between regulators and industry Dr. G.Grohman
before, during and after inspections TGA Q&A and panel discussion Moderated by Dr. N. Dellepiane
Coffee break
Improving manufacturing of priority vaccines in Closed session with DCVMN CEOs only developing countries Venue : Regency V Room Adjourn
Gala dinner with CEOs
All
Venue : Crystal Ball Room (I‐II) 29 October Time Session 4a 9 :00 h 9 :20 h 9:40 h 10:00 h Session 4c 10 :30 h 10:50 h Topic Partnerships Vaccine Standards : a USP perspective Speaker
Venue : Crystal Ball Room (I‐II) Chair/Co‐chair/
Dr.Leite/Dr.Muktadir Dr. D. Saha
United States Pharmacopeia, India Dr. R. Salerno
Sandia Labs Mr. K. Sampson
APACI Biorisk, biosecurity and containment tools for industry Advocacy, Education & Information for flu control in Asia Coffee break
New Vaccine Chair/Co‐
Delivery and chair/Rapporteur Packaging S.Jadhav/ D. Technologies Kristensen Sharing field Dr. R. Steinglass
experiences on new John Snow Inc. vaccine delivery approaches Overview of new D. Zehrung
vaccine delivery PATH technologies Topic
Session 4b 9 :00 h Speaker Venue: Regency I‐II Novel vaccines I
Chair/Co‐chair/ Dr.R.Modi/Dr.A.Nanni EV71 candidate vaccine Mr. W.Meng development Sinovac 9 :20 h Advancements in sIPV developments Mr. R. Suri Panacea Biotec 9:40 h Partnerships for VLPs based vaccines Mr. R. Mehta Cadila Biotech 10:00 h Session 4d Coffee break
Novel vaccines II
Chair/Co‐chair/ Dr.Ella / Dr. C.Campa 10:30 h Vaccines difficult to develop Dr. J. Kalil Butantan 10:50 h Partnerships for vaccine development Dr T. S. Rao DBT 11:10 h 11:30 h 12:00 h 12 :30 h Session 5 13 :30 h 14 :00 h 14 :30 h 15: 00 h 15:30 h 16:00‐16:45h
16:45‐17:30h
17 :30 h 18 :30 h 19 :00 h Nasal and aerosol vaccines Dr. S. Jadhav development SII Trends in Packaging Ms. D. Kristensen
and labelling: bar PATH code and other innovations Q&A
11:10 h 11:30 h 12:00 h Novel vaccines for developing countries needs TB vaccines
Dr. K. Ella Bharat Biotech Dr. A Nanni AERAS Innovations in HPV Mr. S.Liao vaccines Innovax Biotech Lunch break
Fostering global access to vaccines
Chair/Co‐chair/
Venue: Crystal Ball Room (I‐II) Dr. A.Homma/Dr. Dat/ SMART Vaccines: a tool for Vaccine Prioritization
Dr. G.Madhavan IOM JICA partnerships in vaccine manufacturing Mr. Y. Ikeda
JICA Improving the vaccines’ value chain
Mr. C. Collins
Clinton Health Access Initiative Sustainable access to vaccines in MICs Ms. T. Cernuschi EPI/WHO Coffee break
Informal GAVI symposium
For DCVMN members only Informal PAHO RF symposium
For DCVMN members only General Assembly2014:
DCVMN Members only
Interim annual report of operations & budget Chair M. Suhardono/Co‐chair Dr. Harsha Election for EC
DCVMN Members only
Closing ceremony and farewell Dinner with Cultural performance
Venue : Plaza Terrace Garden th
30 October time 8:30‐18:00h Workshops for DCVMN– limited number of seats available
Computer validation systems – PATH workshop (cf. programme on website http://dcvmn‐2014‐
delhi.com/post ‐workshop.html ) Venue : Regency III Room 14:00‐17:30h WHO global Influenza vaccines: splitting technology expert workshop (cf. separate agenda) Venue : Regal Hall 8:30‐13:00h Engineering and GMP compliant systems
Venue : Regal Hall Satellite symposium
Engineering and GMP compliant systems 9 :00 h Concept design for vaccine facilities: how to conciliate local and Mr. K. Hermansen global requirements NNE Pharmaplan 9 :30 h Review of clean rooms layout Mr. A. Relan
Jacobs 10:00 h
Purity of Water, Media and Process Systems – State of the Art Mr. R. Roepenack Solutions for Vaccine Manufacturing Bosch 10: 30 h
Coffee break
11:00 h
HVAC systems at the Core of the GMP Vaccine Facility
T.V.Subrahmanyam and Dr. Estapé M+W 11: 30 h Feasibility of facility upgrade and validation for WHO prequalification
Mr. J.F. Duliere Technip 12:00 h
Flexibility as concept design Mr. J. Lilja
KeyPlants‐Telstar 12:30 h
GMP compliance in process design M. Lundgren GE Healthcare 13:00 h
Lunch break 14:00‐ 18:00 h
Time for private meetings with engineering consulting companies
According to schedules