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APEC Life Sciences Innovation Forum
Anti-Counterfeiting Health Products Seminar
"Building International Cooperation to Protect Patients"

Singapore
January 13-15, 2008 and March 30 - April 2, 2008

The Asia Pacific Economic Cooperation Life Sciences Innovation Forum along with the U.S. Food and Drug Administration, the U.S. Department of Commerce, together with Singapore’s Health Sciences Authority and the U.S. – ASEAN Business Council held a series of two seminars in Singapore to enhance international awareness of the dangers of trade in counterfeit medical products, and to maintain the integrity of the pharmaceutical products and medical devices supply chain.

Objectives for the Seminars included:

  • Assist in the detection and prevention of counterfeit medical products in APEC economies through improved training, coordination, and collaboration among key stakeholders.
  • Encourage the development and implementation of government policies and regulations that combat and deter the production and trade of counterfeit pharmaceutical products and medical devices.
  • Safeguard patient health and promote an environment that is conducive to innovation in the life sciences.
  • Stimulate participant discussion through lower speaker to participant ratios and a case study approach to enhance and broaden practical skills.

The first two-day session was held January 13 through 15, 2008 provided introductory modules on counterfeit hazard, detection and prevention giving regulatory authorities and other stakeholders the tools both to perform training exercises in their local economies and regions throughout Asia and to enhance societal awareness of the hazards of counterfeit pharmaceuticals and medical devices.

The second two-day session was held March 30 through April 2, 2008 and built on the outcomes established during the first seminar focusing on more intensive modules on counterfeit avoidance and deterrence measures. In order to truly combat and prevent trade in counterfeit medical products, a wide variety of stakeholders were exposed to capacity-building activities, policymakers, regulators, customs officials, physicians and representatives from the pharmaceutical and medical devices industries.

This series of seminars complements the efforts of the World Health Organization’s International Medical Products Anti-Counterfeiting Taskforce (IMPACT) formed to develop international initiatives to fight counterfeiting of medical products. IMPACT is a partnership comprised of all major anti-counterfeiting players, including international organizations, non-governmental organizations, enforcement agencies, pharmaceutical manufacturers associations, and drug regulatory authorities.

Activities at the first seminar included:

  • An introductory module on the hazards of counterfeit medical products.
  • A best practices training module on the detection of counterfeit medical products at selected stages in the supply chain.
  • A module examining the unintended consequences of regulations and policies that may inadvertently contribute to the development or continuing existence of black markets.
  • A module on the impact of counterfeit products on innovation and access to advanced medical technology.

For the presentations from the first seminar, please see under "Important Materials" below.

Activities at the second seminar included:

  • Case studies by experts on best practices for preserving the integrity of the supply chain and combating counterfeiting.
  • A module on best practices in deterring anti-counterfeiting at selected points in the supply chain.
  • Agreement on follow-up activities and methods to continue cooperative efforts.

For presentations from the second seminar, please see under "Important Materials" below.

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July: ASEAN Health Ministers Meeting (AHMM). Philippines. Contact: Susan McKinney at smckinney@usasean.org

August: Health & Life Sciences Working Group Meeting. Singapore. Contact: Susan McKinney at smckinney@usasean.org

August 4-9: ASEAN Health Ministers Meeting.. Philippines. Contact: Susan McKinneu at smckinney@usasean.org

November: Health & Life Sciences Working Group Meeting. Singapore. Contact: Susan McKinney at smckinney@usasean.org

more upcoming events

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 Vietnam eyes expansion of biotech industry Thanh Nien, Mar 10

 No cancellation of CL for cancer drugs : Chaiya The Nation, Mar 4

 


Above: Speakers and Presenters of the Seminar

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Presentations from the first seminar:

"Counterfeit Medicines in Southeast Asia", by Dr Krisantha Weerasuriya, WHO Southeast Asia Region

"Counterfeit Medical Products", by Eric McIntosh, TGA AUstralia

"How APEC Economies Combat Counterfeit Medical Products", by Eisah Rahman, Ministry of Health Malaysia

"Counterfeit Drugs Kill", by Dr V Reggi, WHO

"Combating Counterfeit Medicines - Singapore's Perspective ", by Shen Kuan Yee, Health Sciences Authority Singapore

"SCMS Product Integrity Issue", by Tom Layloff, SCMS

"Building Regional Approaches", by Nazarita Tacandong, WHO

"Stop Counterfeit Drugs", by Ilisa Bernstein, US FDA

"Intra-Governmental Collaboration: a measure to deter and detect counterfeiters?", by Duangtip Hongsamoot, Thai FDA

"Building International Cooperation", by Pharmaceutical Security Institute

"Industry Perspective - Assesment of Counterfeiting", by Pharmaceutical Security Institute

"Counterfeit Drugs in the Virtual World: Real World Problem", by R. Velez, Lilly

"Counterfeit Medical Devices - An Industry Perspective", by Johnson & Johnson

"How Counterfeit Products Impact Innovation & Access to Advanced Medical Technologies", by Jennie Ness, US Patent & Trademark Office

Presentations from the second seminar:

Quality of Medicines in Latin America: "Argentine National Program for Research of Illegal Medicines" by Dr. Maximiliano Derecho

Good Manufacturing Practice: A Global Standard for Pharmaceutical Quality by Nick Buhay, US FDA

Advances in Education in Pharmaceutical GMPs in China by Qiang Zheng, Peking University

Making A Killing: The Deadly Implications of Counterfeit Drug Trafficking by Roger Bate

"Building International Cooperation to Protect Patients" by Geeta Thakerar, GlaxoSmithKline

"Stopping the Spread of Counterfeit Medical Products: A Judicial Perspective" by Hon. Randall R. Rader, Circuit Judge, United States Court of Appeals for the Federal Circuit

IMPACT Legislative & Enforcement Recommendations by E. Rahman

IMPACT Principles and Elements for National Legislation against Counterfeit Medical Products

 

 

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