Annex I

PARTICIPANT PROFILE FORM

FOR NOMINATION FROM APEC ECONOMIES ELIGIBLE FOR TRAVEL SUPPORT

APEC Life Sciences Innovation Forum

Drug Safety and Detection Workshop

September 27 to 28, 2011

Beijing, China

Travel-eligible economies should (economies (Indonesia, Malaysia, Papua New Guinea, Philippines, Russia, Thailand, Viet Nam, Chile, Mexico and Peru) should use this form to nominate government officials to receive travel support. Each travel eligible economy can request up to two government officials, with a third official designated as an alternate. Please submit nominations by COB July 26, 2011.

Member Economy/Organization:

Nominee 1Nominee 2

Name: Name:

Position: Position:

Ministry: Ministry:

Email: Email:

Telephone: Telephone:

Fax: Fax:

Alternate Nominee 1

Name:

Position:

Ministry:

Email:

Telephone:

Fax:

Name of nominating official:

Position:

Ministry:

Email:

Telephone:

Fax:

Nomination forms should be submitted by email to Mr. Nimesh Modak () and Ms. Shinta Manurung () of the APEC TATF, copying Mr. Jeffrey Gren () of the U.S. Department of Commerce, copying Evelyn Loh () of APEC Secretariat, by July 26, 2011.

Annex II

HOTEL RESERVATION FORM
APEC TECHNICAL ASSISTANCE & TRAINING FACILITY (TATF)

PLEASE SEND THIS RESERVATION FORM TO THE RESERVATION:

Email address: and please also CC to

Phone: 86-10-83970088

Fax: 86-10-83555063

GUEST NAME: Mr/Ms./Mrs.LAST NAME:FIRST NAME:

TEL:FAX:EMAIL:

ARRIVAL DATE:ARRIVAL TIMEFLIGHT NO:

DEPARTURE DATE:DEPARTURE TIMEFLIGHT NO:

SUPERIOR ROOM SINGLE DOUBLE : RMB 600 includes 1/2 breakfast, in-room internet, Tax & Service Charge

For non-residential breakfast will be charged at RMB 80 per person.

BUSINESS FLOOR SINGLE /DOUBLE : RMB 750 includes 1/2 breakfast, in-room internet, Tax & Service Charge

Additional benefit for guests staying at Business Floors:

Express Check in/out in the Club Lounge, Free flow of tea, coffee and soft drinks through the day in the Executive Club, Evening open-bar cocktail hour in the Executive Club lounge from 6:00pm to 7:30pm, Free local calls & fax.

Holiday Inn Central Plaza Beijing will honor the above rates for early arrival of 3(three) days prior to and late departure of 3(three) days after the main group dates.

REMARK:

Please send this Hotel Reservation Form before 31 August 2011.

Payment: Personal Account

Guaranteed by Credit Card: AMEXVISAMaster Card

Card Holder:______

Credit Card No:______Valid Thru: ______

Note:Check in time: 14:00, Check out time: 12:00noon

Condition: No-show, early departure will be charged to guest’s own account or guest’s credit card

Guest’s signature: ______Date:______

THANK YOU FOR THE RESERVATION AND WE LOOK FORWARD TO WELCOMING YOU TO

Holiday Inn Central Plaza Beijing

北京中环假日酒店

No.1 Caiyuanjie, Xuanwuqu, Beijing 100053, P. R. C. Postcode: 100053

Tele: +8610 83970088 Fax: +86 10 83554737

E-mail: Website:

China Toll Free Tel: 800 830 6368 China Toll Free Fax: 800 830 9288

Annex III

REGISTRATION FORM

APEC Life Sciences Innovation Forum

Drug Safety and Detection Workshop

September 27 to 28, 2011

Beijing, China

All workshop participants are required to complete the below participant registration form. Please complete the below form and e-mail it to Mr. Nimesh Modak () and Ms. Shinta Manurung () of the APEC TATF, copying Mr. Jeffrey Gren () of the U.S. Department of Commerce and Evelyn Loh () of APEC Secretariat, byJuly 26, 2011.

A. Participant’s Information

___Mr. ___Mrs. ___Ms. ___Dr. ___Prof.

Last Name: ______

First Name: ______

Organization: ______

Title: ______

Tel: ______

Fax: ______

Address:______

______

______

Email: ______

Dietary Requests: Vegetarian __ Beef Free __ Pork Free __ None__

Annex IV

DRAFT AGENDA

APEC Life Sciences Innovation Forum

Drug Safety and Detection Workshop

September 27 to 28, 2011

Holiday Inn Central Plaza, 1 Caiyuanjie, Xuanwuqu, Beijing, China

Tuesday, September 27

8:30 - 9:00 Welcome and Introductory Comments

  • SeniorOfficialState Food and Drug Administration of China (invited)
  • Senior U.S. Government Official
  • Lembit Rago,World Health Organization (WHO), Coordinator, Quality Assurance and Safety
  • APEC LSIF Speaker

9:00 - 9:30Keynote Address – The Benefits and Limitations of Detection Technologies inAssuring Genuine Drug Products in APEC Economies (speaker to be determined)

9:30 - 10:00Arun Kumar Panda, Joint Secretary, India Ministry of Health and Welfare, Topic “Medical Implications of Unsafe Medicines and Why Detection Technology is Important for Public Health” (invited)

10:00 - 10:15Jeffrey Gren, U.S. Department of Commerce, Director Office of Health and Consumer Goods and APEC Project Overseer, Summary of APEC LSIF Activities to Combat Falsified Medicines

10:15 - 10:30Tea and Coffee Break

10:30 - 11:30Presentations on Types of Detection Technologies Available - Paper on Detection Technologies to be provided to Workshop Participants Prior to Workshop (examples of technologies to be covered includes film coatings, nano-encryption, florescent markers, sophisticated product and packaging taggants, mass spectrophotomers, HPLC, gas chromatographs, colormetric analyses, overt and covert markings, etc.)

  • Frederick Fricke, Director USFDA Forensic Laboratory, and
  • Ms. Lim Chin Chin, Forensic Laboratory Director Singapore Health Science Authority

11:30 - 12:00Azrul Azwar, President, ASEAN Primary Care Association

Detection Technology from a Patient and Health Provider Perspective

12:00 - 1:00 Lunch

1:00 - 1:15Roger Williams, CEO, US Pharmacopeia (USP), “Improving Global Medicines Quality Through Setting Quality Standards”

1:15 - 2:45 Panel Discussion: The Use of Detection Technologies in APEC Economies: Case Studies and Best Practices

Moderator -Jeffrey Gren, U.S. Department of Commerce

  • Professor Jin Shaohong, China National Institutes for Food and Drug Control (NIFDC) - China Mobile Laboratories
  • Mr. Frederick Fricke, USFDA, Director USFDA Forensic Laboratory
  • Roger Williams, CEO, US Pharmacopeia (USP)
  • Ms. Lim Chin Chin, Forensic Laboratory Director and Forensic Scientist, Singapore Health Science Authority
  • Percy Alberto Ocampo Rujel, Executive Director of the Directorate of Control and Health Surveillance, Peru

Question and Answer Session

2:45 - 3:30Coffee Break and Time to View NIFDC China Mobile Drug Detection Laboratories

3:30 - 5:00Panel Discussion: Detection Technologies as Part of a Larger Strategy for DrugAuthentication Quality

Moderator -Senior Official, International Cooperation Department, State Food and Drug Administration of China

  • Senior Official, Bureau of Investigation and Enforcement, State Food and Drug Administrationof China
  • Official, U.S. Food and Drug Administration (to be determined)
  • Eugene Goh, Singapore Health Science Authority, Product Quality Sampling (PQS) Program
  • Aline Plancon, INTERPOL, Topic – “How the scientific and international community builds bridges to combat falsified medical products”
  • Thomas Kubic, Executive Director, Pharmaceutical Security Institute – Topic “Patient Awareness and Empowerment”
  • Mr. Somsak Sunthornphanich, Thailand Ministry of Public Health, Senior Pharmacist, Bureau of Drug and Narcotics, Department of Medical Science

Question and Answer Session

5:00 Day 1 Adjourns

Wednesday, September 28

8:30 - 9:30 Panel Discussion: Industry Perspectives on Detection Technologies

Moderator - Thomas Kubic, Executive Director, Pharmaceutical Security Institute

  • Official, China Generic Drug Association Representative (to be determined)
  • Jean-Marc Bobee, Director of Industrial Affairs, Sanofi Aventis
  • David Webber, Director General, World Self-Medication Industry (WSMI) (APEC approval pending)

9:30 - 10:00Professor Lin Ruichao, China National Institutes for Food and Drug Control (NIFDC), Chief Expert on Traditional Chinese Medicines Analysis, Topic of Remarks - Detection Technologies Concerning Traditional Chinese Medicines

10:00 - 10:30Susanne Keitel, Director General, European Directorate for the Quality of Medicines and Healthcare, Council of Europe – Council of Europe Anti-counterfeit Medicines Convention and Serialization and E-pedigree and the Benefits of Compatibility of Regulatory Requirements

10:30 - 10:45Coffee Break

10:45 - 12:15Panel Discussion: The Role of Serialization in the Detection and Prevention of Counterfeits (Key message – Serialization helps to protect the legitimate supply chain. This is a key area for APEC cooperation.)

ModeratorSusanne Keitel, Director General, European Directorate for the Quality of Medicines and Healthcare, Council of Europe

  • Ulrike Kreysa, GS1, Vice President Healthcare, Topic – “GS1 Serialization and E-pedigree Standards Activities, as an Example”
  • USFDA Speaker
  • Speaker from APEC Economy Implementing Serialization and E-pedigree
  • Jean-Marc Bobee, Director of Industrial Affairs, Sanofi Aventis

Question and Answer Session

12:15 - 1:15 Lunch

1:15 - 2:45 Panel Discussion - Early Detection and Data Collection

Moderator - To be Determined

  • USFDA Speaker (WHO system)
  • Anthony Zook, Merck (sampling)
  • Additional Speakers to be Determined (insert topic)

2:45 - 3:00Coffee Break

3:15 - 4:45Concluding Session – Ensuring a Holistic Strategy for Improving Drug Quality (Open Discussion with Attendee Participation on Next Steps and Future Activities)

Facilitators:

  • Dr. Li Bo, Deputy Director of NIFDC and
  • Jeffrey Gren, U.S. Department of Commerce, Director Office of Health and Consumer Goods and APEC Project Overseer

Topics:

  • Developing Report on Available Detection Technologies and Best Use
  • Implementation of the APEC LSIF Anti-counterfeit Medicines Action Plan
  • The Benefits of PublicPrivate Partnerships
  • Global Cooperation

4:45 - 5:00Concluding Comments

  • Lembit Rago,World Health Organization (WHO), Coordinator, Quality Assurance and Safety
  • Senior U.S. Food and Drug Administration Official
  • Mr. Li Yunlong, Director General NIFDC