12/31/09
APEC - Funded Medical Devices Regulatory Harmonization Delegation
Visit to Canada and the United States
August 8 - 18, 2010 • Ottawa, Canada; Boston, Massachusetts or
Minneapolis, Minnesota; and Washington D.C., USA
Health Canada, the U.S. Food and Drug Administration
(USFDA), the Global Harmonization Task Force (GHTF), the Pan American Health
Association (PAHO), the Latin American Harmonization Working Party (LAHWP), the
Asian Harmonization Working Party (AHWP), the U.S. Department of Commerce
(USDOC), and the Advanced Medical Technology Association (AdvaMed) present the
latest in the series of APEC-funded projects educating regulators on global
harmonization of medical devices regulation.
AdvaMed will coordinate with U.S. and Canada industry in organizing the
industry portion of this delegation visit.
Participation in this delegation visit will help you
as a regulator to better understand global medical device regulations and the
emerging similarities between them. This
delegation visit builds upon a similar APEC-funded September 2009 delegation
visit of APEC Asia medical devices regulators to Australia. The focus of the August 2010 delegation visit
will be training, laboratory visits, and training conducted by regulatory
government and industry regulatory experts involved in GHTF, with a
concentration on how two of the GHTF founding members (Health Canada and USFDA)
implement their regulatory regime including auditing, quality system and
surveillance. English – Spanish
simultaneous translation will be provided during all training activities and
firm visits. While this August 2010 delegation visit
to Canada and the United States is an APEC-funded project, with focus on Latin
American APEC economies, all APEC economies are welcome to participate. APEC has also authorized the following
non-APEC economies to participate - Argentina,
Bolivia, Brazil, Colombia, Costa Rica, El Salvador, Honduras, Nicaragua,
Panama, Uruguay, India,
Laos, and Cambodia.
See
the schedule of activities during the delegation visit listed on page two of
this announcement. The trainers during this delegation
visit will make presentations, participate in panel discussions, lead group discussions and present case studies. Due to space limitations we will need to
limit the total delegation size to 30 regulators. While this will be essentially done on a
first-come first-serve basis, we may need to limit the number of regulators per
economy if more than 30 regulators register, so the registration deadline is
important.
Who should attend the
Workshop? Representatives from: ·
APEC member
economies with established or developing medical regulatory systems ·
Non APEC
member economies with established or developing medical regulatory systems (APEC has authorized
limited non-APEC Asia regulators participation from the following economies Argentina, Bolivia, Brazil, Colombia, Costa Rica,
El Salvador, Honduras, Nicaragua, Panama, Uruguay, India,
Laos, and Cambodia). Workshop’s objectives: ·
Understanding
GHTF recommendations on issues relating to regulation, auditing, quality
systems and surveillance ·
Practical
training sessions achieved through a smaller instructor to student ratio,
using case studies and interactive discussion between instructors and
students ·
Providing
guidance on the role of regulators, industry, and distributors in
regulatory harmonization and securing the integrity of the medical devices
supply chain.
LIMITED FUNDS FOR SUBSIDIZED TRAVEL
There are limited funds available for travel
support (the cost of round trip economy-class airfare, lodging, and per diem costs) for two medical devices
regulators from the three APEC Latin America economies: Mexico, Peru, and
Chile. If you are a government official
from one of these economies and you wish to be considered for the travel
support available, please send an e-mail to Gerry Zapiain at
gerry.zapiain@trade.gov and Jeffrey Gren at jeffrey.gren@trade.gov. Please include your name, position, agency or
ministry, and full contact information. We will need this e-mail submitted no
later than May 26, 2010. You
will be notified if you are selected for the travel support by June 25, 2010.
In addition, the USDOC is seeking
additional travel funds from APEC for two regulators from each of the following
Asian APEC travel-eligible economies: China, Indonesia, Malaysia, Papua New
Guinea, Philippines, Russia, Thailand and Viet Nam. If you are a government official from one of
these Asia economies, please email your interest to Gerry Zapiain and Jeffrey
Gren at the above email addresses. Upon
approval of the funds requested from APEC, two regulators from each of these
Asia economies will be considered for travel subsidies on a first-come,
first-served basis.
LIMITED FUNDS FOR SUBSIDIZED TRAVEL
Subsidized Travel Support for Latin American APEC
Regulators -
There are limited funds available for travel support (the cost of round trip
economy-class airfare, lodging, and per
diem costs) for two medical devices regulators from the three Latin America
APEC economies: Mexico, Peru, and Chile.
If you are a government official from one of these three Latin American
APEC economies and you wish to be considered for the travel support available,
please send an e-mail to Gerry Zapiain at gerry.zapiain@trade.gov and Jeffrey
Gren at jeffrey.gren@trade.gov. Please
include your name, position, agency or ministry, and full contact information.
We will need this e-mail submitted no later than May 26, 2010. You will be notified if you are selected for the
travel support by June 25, 2010.
Subsidized Travel Support for Asian APEC Regulators
- The USDOC is
seeking additional travel funds to enable a limited amount of funding for
regulators from the following Asian APEC travel-eligible economies: China,
Indonesia, Malaysia, Papua New Guinea, Philippines, Russia, Thailand and
Vietnam. If you are a medical devices
regulator from one of these Asia economies, please e-mail your interest to
Gerry Zapiain and Jeffrey Gren at the above e-mail addresses. For the responses received from eligible Asia
APEC regulators we will note your interest and we will send you an announcement
if the additional funds become available. Of course, all APEC Asia economies
can self fund participants.
APEC
- Funded Medical Devices Regulatory Harmonization Delegation Visit to
Canada and the U.S. August
8 - 18, 2010 • Ottawa, Canada; Boston, Massachusetts or Minneapolis,
Minnesota; and Washington D.C., USA
Sunday, August 8
6:30 pm - 8:30 pm Informal
Dinner at (to be determined)
(No-host, optional for those attending at their own cost)
Monday, August 9
8:30 am - 9:00 am Registration
9:00 am - 5:00 am Training
Program Conducted by Health Canada
Tuesday, August 10
9:00 am - 5:00 am Training
Program Conducted by Health Canada
7:30pm - 9:30 pm Possible US DOC
hosted dinner
Wednesday,
August 11 Travel from
Ottawa to Boston or Minneapolis and free time (delegation members will be required
to book their own travel reservations, and recommended flights will be provided
in advance)
Thursday, August 12
8:30
am - 5:00 pm Industry Portion of the Training Program for Two Days to be Coordinated by AdvaMed in Boston or
Minneapolis
Friday, August
13
8:30 am - 5:00 pm
Training
Program and Company Visits Coordinated by AdvaMed
7:30 pm - 9:30 pm Reception/Dinner
Hosted by Industry
Saturday,
August 14 Travel from
Boston or Minneapolis to Washington DC and free time in Washington DC
(delegation members will be required to book their own travel reservations, and
recommended flights will be provided in advance)
Sunday,
August 15 Sightseeing in
Washington, DC
Monday,
August 16
9:00 am - 5:00 pm Training
Program Conducted by US Food and Drug Administration and hosted at the USDOC
Tuesday,
August 17
9:00 am - 5:00 pm Training
Program Conducted by US Food and Drug Administration and hosted at the USDOC
6:30 pm - 8:30 pm Reception/Dinner
Hosted by Industry
Wednesday,
August 18
8:30 am - 5:00 pm Training
Program Conducted by US Food and Drug Administration and hosted at the USDOC
APEC
- Funded Medical Devices Regulatory Harmonization Delegation Visit to
Canada and the U.S. August
8 - 18, 2010 • Ottawa, Canada; Boston, Massachusetts or Minneapolis,
Minnesota; and Washington D.C., USA
To
register for the delegation visit, please email or fax this registration form
(two pages) to:
Gerry Zapiain
US Department of Commerce, Office
of Health and Consumer Goods
Washington DC
20230, Room 1015
Tel: +011 202 482 2410
Fax: +011
202 482 0975
Email: Gerry.Zapiain@trade.gov
Last
Name: _____________________________________ First Name: ___________________________________________
Title/Position:________________________________
Organization/Country: ___________________________________
_____________________________________________
Tel:
____________________________________________ Fax:
__________________________________________________
Mailing
Address:
______________________________________________________________________________________
_______________________________________________________________________________________________________
Email: ____________________________
B. Your
confirmation on the following dinner arrangement is required.
Dietary
Requests: Vegetarian □ Beef
Free □ Pork
Free □ None □ Others □_____
I
will attend the official hospitality dinner on August 11 Yes □ No □
I
will attend the industry hospitality dinner on August 13 Yes □ No □
I
will attend the industry hospitality dinner on August 17 Yes □ No □
APEC
- Funded Medical Devices Regulatory Harmonization Delegation Visit to
Canada and the U.S. August 8 - 18, 2010 • Ottawa, Canada; Boston, Massachusetts or Minneapolis,
Minnesota; and Washington D.C., USA
REGISTRATION
The last day for registration
is June 15, 2010. There is a limited
capacity for participants during the delegation visit. Attendees will be
accepted on a space-available basis. All hotel rates quoted below are in Canada
or US dollars.
HOTEL RESERVATIONS (to be added)
1)
Ottawa –
2)
Boston –
3)
Washington DC –
Please note that bookings
have been made with the above hotels for the workshop attendees. However, you
are required to finalize your hotel reservation by contacting each of the
hotels directly using the information
provided below. You will be asked to
provide your credit card details and quote the group booking reference codes by
the respective hotel staff to secure your booking.
The above special room rates
apply for reservations made by----------.
After this date, availability cannot be guaranteed and prevailing room rates
will apply.
□ I will be staying at the ----------- in Ottawa. I will check in on August ____, Checkout is
August 11 and I agree to confirm my room booking directly with the hotel.
□ I will be staying at the ………… in Boston. Check in is August 11, check out is August 14,
and I agree to confirm my room booking directly with the hotel.
□ I will be staying at the ………… in Washington DC. Check in is August 14 and I will be checking
out on August ___. I agree to confirm my
room booking directly with the hotel.
After the group reservations
expires on ……….., it will be your own responsibility
to find a suitable hotel for your stay in Ottawa, Boston or Washington DC.
LIMITED FUNDS FOR SUBSIDIZED TRAVEL
Subsidized Travel Support for Latin American APEC
Regulators -
There are limited funds available for travel support (the cost of round trip
economy-class airfare, lodging, and per
diem costs) for two medical devices regulators from the three Latin America
APEC economies: Mexico, Peru, and Chile.
If you are a government official from one of these three Latin American
APEC economies and you wish to be considered for the travel support available,
please send an e-mail to Gerry Zapiain at gerry.zapiain@trade.gov and Jeffrey
Gren at jeffrey.gren@trade.gov. Please
include your name, position, agency or ministry, and full contact information.
We will need this e-mail submitted no later than May 26, 2010. You will be notified if you are selected for the
travel support by June 25, 2010.
Subsidized Travel Support for Asian APEC Regulators
- The USDOC is
seeking additional travel funds to enable a limited amount of funding for
regulators from the following Asian APEC travel-eligible economies: China,
Indonesia, Malaysia, Papua New Guinea, Philippines, Russia, Thailand and
Vietnam. If you are a medical devices
regulator from one of these Asia economies, please e-mail your interest to
Gerry Zapiain and Jeffrey Gren at the above e-mail addresses. For the responses received from eligible Asia
APEC regulators we will note your interest and we will send you an announcement
if the additional funds become available. Of course, all APEC Asia economies
can self fund participants.