Medical Devices Regulatory Capacity Building Training Program for AHWP, ASEAN, Latin American and Other Medical Devices Regulators, March 27-28, 2014

By Effective Medicine  On  In Medical Devices Tagged  

  • Preliminary Announcement and Invitation to Attend
  • Training Registration Form
  • Lodging Information
  • Draft Agenda
  • Additional Training Opportunity

Preliminary Announcement and Invitation to Attend

Background:  The U.S. Department of Commerce and U.S. FDA invite global medical device regulators to participate in a two-day regulatory capacity building training program in collaboration with the World Health Organization (WHO) to take place on March 27-28 in San Francisco on the margins of the International Medical Devices Regulator Forum (IMDRF) March 25 meeting and the March 26 IMDRF stakeholders forum.  The draft agenda for this workshop can be found in the Draft Agenda section.  Space for workshop participation is limited, so medical devices regulators are encouraged to register through the below e-mail addresses as soon as possible.  The workshop will be held in English and translation will not be provided and there will not be a registration fee to participate in this workshop.

Workshop Scope:  The workshop’s objectives are to share information of medical devices regulation based upon the Global Harmonization Task Force (GHTF) global model and in sharing information on the U.S. medical device regulatory system, including basic and advanced topics such U.S. registration and listing, device approvals/clearances, as well as Supply Chain Controls, Unique Device Identifiers (UDI), Software review practices and Combination Products.

Participants and Registration:  Anticipated workshop attendees are medical device regulators from APEC, ASEAN, Latin American and other economies.  To register, complete the registration form and e-mail this form to [email protected].

Lodging Information:  The workshop will take place at the Westin San Francisco, Market Street, 50 Third Street, San Francisco, California, 94103 (tel: 415.974.8719).  Information is available regarding lodging near the workshop venue at a special negotiated rate.  Participants will be responsible for their own lodging costs and reservations.  See this section for further lodging details. 

Contacts:
Mr. Gerry Zapiain, U.S. Department of Commerce, [email protected]; 202 482 2410
Ms. Jane Earley, U.S. Department of Commerce, [email protected]; 202 482 6241

U.S. Visa Information: Visa requirements to enter the United States can be obtained on the following U.S. State Department website (travel.state.gov/visa/).  If a visa invitation letter is required for travelers from your country or economy, please request this letter from the contacts listed above, Gerry Zapiain or Jane Earley, including your arrival and departure date information.

Additional Training Opportunity:  On March 24. 2014 the Medical Device Epidemiology Network (MDEpiNet) Medical Device Epidemiology Network (MDEpiNet), a Public Private Partnership of international medical doctors, medical professional societies, academia, and health care systems involved with medical devices registries responsible for the International Consortium of Orthopedic Registries (ICOR) and the new International Consortium of Cardiovascular Registries (ICCR) will be offering a training/think tank program. Additional details can be found in the Additional Training section.

[email protected], copying Mr. Gerry Zapiain ([email protected]) of the U.S. Department of Commerce by February 15, 2014.

  • Full Name (Mr., Mrs., Ms., Dr.)
  • Organization
  • Economy/Country
  • Title
  • Number of Years Experience as a Medical Devices Regulator
  • Email Address
  • Telephone Number
  • Fax Number

Lodging Information

To accommodate the needs of participants, the Department of Commerce has negotiated a limited special rate of $189 plus tax with the Galleria Park Hotel for the nights of March 26, 27, and 28, 2014.

Please note that these special rates apply for reservations made by February 26.  After that date, availability cannot be guaranteed, and prevailing room rates may apply. 

Hotel information:

Galleria Park Hotel (three blocks north of Westin Hotel)
191 Sutter Street
San Francisco, California 94104

Reservations can be made at the hotel’s website www.galleriapark.com using the booking code 1403USDEPA, or by calling 800.792.9639 within the United States, or at +1.415.781.3060 for international callers. 

After the group reservations expire on the date indicated above, it will be your own responsibility to find suitable arrangements for your stay in San Francisco for the Medical Devices Regulatory Capacity Building Training Program. 

[email protected].




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