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2012/CTI2/LSIF/001
Agenda
Purpose: Consideration
Submitted by: LSIF PG Chair
/ Life Sciences Innovation Forum Planning Group MeetingSingapore
31 March 2012
LSIF Planning Group Meeting
Saturday, 31 March 2012
9:00 – 12:30
14:30 – 18:00
Conference Room 2
Sands Expo and Convention Center
10 Bayfront Avenue
Singapore
MEETING AGENDA
LSIF Planning Group (LSIF PG) will convene in Singapore on March 31 to review work underway in the LSIF, the LSIF committees, and in collaboration with other APEC fora. Delegates will (1) review key action items from the February 2 LSIF PG meeting in Moscow, Russian Federation; (2) receive a report on the progress of the LSIF Regulatory Harmonization Steering Committee; (3) receive updates on pending projects; and (4) review preparations for the series of the health and life sciences related meetings to be held June 26 – 30 in St. Petersburg, Russian Federation, including the 10th Life Sciences Innovation Forum (LSIF X) and the High Level LSIF-HWG Joint Event.
REVIEW OF 2012 WORK STREAMS
I. Advancing Regulatory Convergence
A. Regulatory Harmonization Steering Committee
A progress report will be received from the LSIF Regulatory Harmonization Steering Committee on the discussions and outcomes of the first set of RHSC meetings of 2012, including progress on developing roadmaps for Priority Work Areas (PWAs) for regulatory convergence. PWAs include: Global Drug Integrity and Supply Chain; Good Review Practices (TFDA); Biosimilars (KFDA); Cellular Therapies (HSA); MRCTs; Good Clinical Practice Inspection (Thai FDA); Pharmacovigilance (AHC/KFDA); and Combination Products (TBC).
The RHSC Chair will ask individual economies to provide expert POCs for various PWAs. The RHSC Chair will also discuss the RHSC’s objectives for the rest of the year, including its next meeting in Kazan in May.
Summary report to be provided by the RHSC Chair
B. APEC Harmonization Center
A progress report will be received from the APEC Harmonization Center. The AHC Director will discuss the AHC’s work this year including the upcoming AHC Workshop on Biosimilars.
Summary report to be provided by the AHC Director
C. LSIF Drug Safety and Detection Technology Workshop
The United States will present on the LSIF Drug Safety and Detection Workshop held September 27 to 28, 201.
Discussion led by the United States
D. APEC Regulatory Cooperation Plan
At the February 2 Moscow meeting, the LSIF Planning Group agreed to complete a template (in consultation with the RHSC) issued by Senior Officials to show how the LSIF is implementing principles contained in the APEC Regulatory Cooperation Plan. Economies will discuss a plan for completing the template.
Discussion led by LSIF PG Chair
E. Sub-Committee on Standards and Conformance
At the Moscow LSIF Planning Group meeting, the LSIF PG Chair asked the SCSC to consider opportunities for LSIF participation in the 9th conference on standards and conformance. The LSIF PG Chair will discuss LSIF involvement in the 9th standards and conformance conference.
Discussion led by LSIF PG Chair or SCSC Representative
F. Transparency & Stakeholder Consultation
Economies were requested to provide summaries of current practice in terms of transparency and stakeholder consultation in the process of regulatory and policy reform in the health and life sciences sectors by March 15. Economies will present 5 minute summaries of their transparency and stakeholder consultation practices.
Discussion led by LSIF PG Chair
II. Strengthening Health Systems
A. Implementation of the APEC NCD Action Plan
Implementation of the APEC Action Plan for the prevention and control of non-communicable disease is a joint activity with the Health Working Group. LSIF Planning Group members were circulated the NCD Action Plan Implementation Template and requested to consult officials within their governments on ideas for implementing the NCD Action Plan. Economies will present project ideas or examples of projects already under development they have identified.
Discussion led by the United States
B. Private Sector Perspectives on the Implementation of the APEC NCD Action Plan
The LSIF Industry Co-Chair will provide an overview of the Economist Intelligence Unit Healthcare in Asia 2012 Conference titled Healthcare outcomes in Asia: a new approach for efficiency and effectiveness. The Co-Chair will give thoughts on how economies could begin implementation of the APEC NCD Action Plan and discuss opportunities for public-private collaboration.
Presentation by the LSIF Industry Co-Chair
C. ABAC Briefing on Global Private Sector Health & Wellness Programs
An ABAC representative will discuss ABAC’s plans to collect examples of employee health and wellness programs from businesses throughout the APEC region.
Presentation by ABAC Representative
D. Investing in Maternal, Newborn and Child Health: Analysis of the Costs, Benefits and Returns
The LSIF Academic Co-Chair will discuss a new collaboration with the WHO to investigate in detail the costs and benefits of large scale investment in health innovation in relation to maternal, newborn and child health, for an agreed group of APEC economies.
Discussion led by the Advisor to the LSIF Co-Chairs
E. Discuss preparations for Upcoming Joint LSIF-HWG High-Level Health Event & LSIF X Meeting
A representative of the Russian Federation will discuss plans for holding a high level joint LSIF-HWG event in St. Petersburg, Russian Federation in June. A representative from the HWG will discuss preparations for the event and actions that need to be taken by economies. The Advisor to the LSIF Co-Chairs will discuss plans for the LSIF X meeting.
Discussion led by the Russian Federation, HWG Representative, and Advisor to the LSIF Co-Chairs
III. Promoting Innovation in Life Sciences
A. Reinvigorating the LSIF Research Committee
Economies acknowledged the need to re-invigorate the LSIF research agenda given Russia’s priority for this year: “intensive cooperation to foster innovative growth.” It was recommended that the LSIF seek nominations for a new LSIF Research Committee Chair. Intersessionally the LSIF Secretariat undertook to consult with the Research Committee on developing a plan for reviving LSIF research activities and possibly establishing a virtual working group, but committee members have been unresponsive. The LSIF Secretariat has recommended that the LSIF Planning Group discuss rebuilding the Research Committee membership and identify potential institutions with which to pursue collaborative activities.
Discussion led by LSIF PG Chair
B. Enabling Innovation in Life Sciences
Canada will present on the completion of the LSIF Enablers of Investment Checklist.
Discussion led by Canada
C. Health ICT
Economies will discuss how the LSIF can contribute to the June HWG Policy Dialogue on Health IT led by Chinese Taipei.
Discussion led by Chinese Taipei
IV. LSIF Projects
A. Healthcare-associated infections – United States
The United States will report on work underway on the Healthcare-associated infections (HAIs) workshop scheduled for July 24-26, 2012 in Manila. A representative from the private sector will also present on the objectives of the workshop.
Presentation by Mr. Bill Bishop, Director, Corporate Affairs
Nippon Becton Dickinson Company, Ltd.
B. Marine Microorganisms: Capacity Building for a Broader Cooperative Research and Utilization – Russian Federation
The Russian Federation will report on work underway on the marine micro-organisms project, which began on November 1, 2011. Russia will provide an update on the project’s activities planned for 2012 including a seminar to be held in Vladivostok in May/June 2012.
Presentation by the Russian Federation
ADDITIONAL BUSINESS
I. Business Ethics
The LSIF has recognized the valuable work underway in the SME Working Group on business ethics, specifically in sectors where SMEs are an important constituency.
A. APEC Workshop: “Drafting Voluntary Codes of Business Ethics for the Medical Device Sector” (Brunei)
A representative from the private sector will report on work underway for the workshop scheduled for April 22 - 24, 2012 in Brunei.
Presentation by the Advisor to the LSIF Co-Chairs
B. APEC Workshop: “Drafting Voluntary Codes of Business Ethics for the Biopharmaceutical Sector” (St. Petersburg, Russia)
A representative from the private sector will report on work underway for the workshop scheduled for July 29 - 31, 2012 in St. Petersburg.
Presentation by Ms. Nancy Adams, Deputy Vice President, PhRMA