2011 APEC Good Review Practice Workshop. on Medical Products. Administrative Circular. Information and Guidelines. Chinese Taipei

Transcription

1 2011 APEC Good Review Practice Workshop on Medical Products Administrative Circular Information and Guidelines Chinese Taipei October 11-15, 2011

2 TABLE OF CONTENTS Page 1. Purpose Conference Information Agenda Registration 2 5. Travel Fund 2 6. Accommodation 4 7. General Information Taipei City Taipei MRT Climate People, Language, Religion Visa Currency and Banks Electricity Communications Local Time Access to The Grand Hotel 9 ANNEX. A. Registration Form B. Hotel Reservation Form C. Map of Taoyuan International Airport. 13. D. Transportation Information

3 1. PURPOSE In order to raise awareness and adopt Good Review Practice among regulatory authorities and stakeholders within the APEC region as well as to reduce regulatory burden and achieve timely market access of medical products, Chinese Taipei will hold a series of APEC Good Review Practice Workshops on Medical Products covering both pharmaceuticals and medical devices, specifically addressing the fundamental elements of a well-designed regulatory review system and also providing complementary modules on good review practices and approaches to the exchange and the use of product assessment reports among regulatory authorities and further promoting regulatory efficiencies and best practices. Trainees and presenters of the workshop are expected to include regulatory officials and experts from health authorities, academia and industry within the APEC region. Participating economies will be able to recognize the importance of good review practices to a well-functioning regulatory system and to establish mutual confidence in the assessment reports of regulatory authorities within the APEC region. Participants will also have an appreciation of how the reports of other trusted agencies may be systematically used to improve the overall efficiency and effectiveness of their product assessment processes, which may lead to changes in review behavior and policy amendment for developing their own regulatory practice. 2. CONFERENCE INFORMATION Date: October 11-15, 2011 *Arrival in Taipei on Oct. 11, *Open to industries on Oct. 15, 2011 Venue: Evergreen International Convention Center, Chang Yung-Fa Foundation No.11, Zhongshan S. Rd., Zhongzheng Dist., Taipei City 100, Chinese Taipei Organizer: Food and Drug Administration, Chinese Taipei - 1 -

4 3. AGENDA Please access the website at to download the program. 4. REGISTRATION Participants from all APEC economies are welcomed and invited to attend this workshop, especially targeted on chief officials or senior reviewers who also hold decisive roles from regulatory authorities. Non-authorities representatives are welcomed to attend this workshop on October 15 which is the only day open to the public. Please refer to Annex A for the registration form for APEC economy authority representatives as well as the registration form for non-authorities. Please submit your complete registration form before August 26 to the Conference Secretariat Ms. Amanda YEH at amandayeh@mpat.org.tw. 5. TRAVEL FUND For APEC Fund, please complete the registration form by August Travel fund is available for up to two participants from each APEC travel-eligible economy: Chile, China, Indonesia, Malaysia, Mexico, Papua New Guinea, Peru, Russia, Thailand, the Philippines and Viet Nam. 5.2 All supported participants must be approved by the APEC Secretariat. For supported participants, APEC Fund will provide round trip Economy Class Flight Ticket and per diems of US$275 (approximately NTD8,175 before tax at NTD30 to US$1) per day for a maximum of four days from October 11 to 14, 2011 to cover accommodation, meals and other incidental. Reimbursement for travel will be coordinated by APEC Secretariat. The Conference Organizer, Chinese Taipei will be responsible for supported participants as the following package: (1) Round trip airport limousine (arranged through the Conference Secretariat) between Taoyuan CKS International Airport and - 2 -

5 Taipei city, and (2) Per diem of US$275 (approximately NTD8,175 before tax at NTD30 to US$1) to cover accommodation, meals and other incidental occurred on October 15 and/or 16, Applicants are supposed to obtain an airfare quotation for a cheapest round trip, restricted/discounted and most direct economy class ticket from your home economy to event-holding economy. The itinerary and quotation as well as costs of travel should be sent to Mr. Steve Chen (sc@apec.org) with a copy to Ms. Mary Tan (mt@apec.org) at the APEC Secretariat by September 2 for approval. Once the airfare quotation and costs of travel is approved, a copy of the travel undertaking will be sent to you. The undertaking is a simple form of contract between the funded participant(s) and the APEC Secretariat. The travel undertaking must be signed and provided to APEC Secretariat as well as a copy to Ms. Amanda YEH by September If a travel-eligible economy has more than one APEC Funded participant, the approval airfare limit for all the APEC Funded participants under the same economy will be the same with the understanding that their departing city is the same. 5.5 The APEC Secretariat will contact with applicants from the aforementioned travel-eligible economies for further details and arrangement concerning the APEC fund. 5.6 The APEC Secretariat may permits on request, the payment of advances for travel expenses (air fare and per diem) to travelers from travel-eligible economies. Such payments will only be made after receipt of a signed advance travel undertaking. APEC Funded participant who wishes to request for advance payment should send in the request (in the form of an ), together with the airfare quotation, to Mr. Steve Chen (sc@apec.org) with a copy to Ms. Mary Tan (mt@apec.org) at the APEC Secretariat by September 2. **Please note that applicants should send the airfare quotation prior to purchasing or finalizing the travel arrangement to APEC Secretariat. All the travel arrangement without approval will NOT be reimbursed. Due to the limited available funding, please submit your application as soon as possible

6 Contact Persons: Mr. Steve Chen Program Director APEC Secretariat 35 Heng Mui Keng Terrance, Singapore Tel: Fax: Ms. Mary Tan Program Executive APEC Secretariat 35 Heng Mui Keng Terrance, Singapore Tel: Fax:

7 6. ACCOMMODATION 6.1 The Grand Hotel is the lodging accommodation of this workshop for APEC economy chief officers or senior reviewers from regulatory authorities and stakeholders. Workshop venue is located in the different place from The Grand Hotel. The Grand Hotel No. 1, Sec 4, Zhongshan N. Rd, Zhongshan Dist., Taipei City, 10461, Taiwan(R.O.C.) Tel: Fax: Website: 6.2 Please refer to the following information for rates: Single room- NTD 5,740 / night (Including 1 breakfast) Twin room- NTD 6,190/ night (Including 2 breakfasts) Room Charges are subject to changes. Payment is to be made in New Taiwan Dollars. The average exchange rate has been NT$ 29 to US$ Please your hotel reservation form Annex B to the Conference Secretariat Ms. Amanda YEH at amandayeh@mpat.org.tw. Hotel reservation will be confirmed directly by Ms. Amanda Yeh. Hotel payment will be charged directly by the hotel while checking-out. 6.4 One night room charge will be imposed in the event of NO-SHOW on the day of arrival unless notified as required by the hotel. 6.5 APEC Fund participants are responsible for all room charges, 10% service fee and incidental expenses, including the internet, mini bar and so on which should be settled upon check-out

8 6.6 No lodging will be assigned to industry representatives by the Conference Secretariat. Please book accommodation hotel for your industry representatives through hotel website. * For further enquiries, please contact: Ms. Amanda YEH Conference Secretariat 3F, No.4, Jen-Ai Rd., Sec.1, Taipei, Chinese Taipei amandayeh@mpat.org.tw Tel: ext.24 Fax: GENERAL INFORMATION 7.1 Taipei City Taipei City is located in the Taipei Basin in northern Chinese Taipei. It is bordered by the Xindian River on the south, and the Danshui (Tamsui) River on the west. The northern districts of Shilin and Beitou extend north of the Keelung River and are bordered by Yangmingshan National Park. The Taipei city limits cover an area ranked sixteenth of twenty-five among all counties and cities in Chinese Taipei. Please visit Taipei City government s website for more information: Taipei MRT The Taipei Rapid Transit System, also known as the MRT (Metropolitan Rapid Transit), or the Taipei Metro is a rapid transit system serving a large part of the Taipei metropolitan area. The network includes 101.9km of rail with 94 stations. Due to its efficiency and affordability, the Taipei Metro system is a common mode of public transport in Metropolitan Taipei, with over 1.5 million trips made in an average during weekdays. You can visit the majority of tourist attractions by taking MRT. The price of the tickets arranges from NTD $20-$60, depending on the distance

9 Please visit the website of Taipei MRT for more information:

10 7.3 Climate Chinese Taipei enjoys warm weather all year round. The strongest fluctuations in weather conditions are during spring and winter, while during summer and autumn the weather is relatively stable. The annual average temperature is comfortable 22 degrees Celsius with lowest temperatures ranging from 12 to 17 degrees Celsius. Average temperature for summer ranges from 28 C to 36 C. 7.4 People, Language, Religion The population of Chinese Taipei is 23 million. The majorities of people inhabit in west coast, and densely populated in Northern part of this island. There are three major languages spoken in Chinese Taipei: Mandarin Chinese, Min-nan, and Hakka. The official language of Chinese Taipei is Mandarin Chinese (Guoyu). The most popular foreign language in Taipei is English, which is part of the regular school curriculum. Chinese Taipei is highly diversified in terms of religious faith, with the practice of Buddhism, Taoism, Christianity, Mormonism, the Unification Church, Islam, and Hinduism, as well as native sects such as Yiguandao and others. 7.5 Visa The Following APEC member economies may enter Chinese Taipei under the visa-exemption program: Australia, Canada, Japan, Republic of Korea, Malaysia, New Zealand, Singapore and the United States. APEC Business Travel Card ABTC Holders of Australia, Chile, Republic of Korea, Indonesia, Peru, Thailand, Japan, Malaysia, Singapore, New Zealand, Philippines, Brunei Darussalam, the Papua New Guinea, Viet Nam and Mexico may enter Chinese Taipei with the visa-exemption within the validity of the ABTC for three months

11 Passport holders from Thailand, the Philippines, Vietnam and Indonesia also in possession of a valid visa or permanent residence certificate issued by U.S.A., Canada, Japan, UK, Schengen Convention countries, Australia or New Zealand are eligible for the visa exemption program, which permits a duration of stay up to 30 days. For further details: 2 Business persons entering Chinese Taipei under the visa-exemption program are eligible to stay up to 30 days, which is not extendable. Foreigners who intend to engage in business for a period of less than six months may apply for a visitor visa. A business person and his/her accompanying family members may be issued visitor visas to Chinese Taipei simultaneously with the same terms and conditions. Documents verifying family relationship may be required for necessary screening. For further details:

12 7.6 Currency and Banks The Country s currency is the New Taiwan Dollar (NTD). The exchange rate in recent months is around NTD29 for US$1. Foreign currencies can be exchanged at hotels, government-designated banks and airports. Major credit cards are widely accepted, and traveler s checks may be accepted by tourist-oriented shops and at most international tourist hotels and banks. Banks open whole day from 09:00 to 15:30, Monday to Friday, and close on the weekends and public holidays. 7.7 Electricity Chinese Taipei's electric current is 110 V, 60 Hz which is the same as the U.S. and thus the wall sockets are made for standard American 2 pin flat plugs. 7.8 Communications There are three mobile phone networks - GSM 900 / 1800, 3G. Broadband internet services are available in all major cities. Here is a list of useful telephone numbers: 7.9 Local Time Police: 110 (toll-free) Emergencies/Ambulance/Fire Brigade: 119 (toll-free) Information for Foreigners: Domestic Overseas The standard time of Chinese Taipei is GMT Access to The Grand Hotel We kindly suggest you making your destination to Taoyuan International Airport (TIA) for your convenience of traveling to the the Grand Hotel. Please refer to ANNEX D for airport transportation information as well as map around the Grand Hotel. Please visit the website of TIA for more information:

13 Annex A 2011 APEC Good Review Practice Workshop on Medical Products Participation First Name Registration Form for APEC Economy Authorities *Please fill in the registration form with CAPITAL LETTERS. October Drug Sessions Device Sessions (Please choose one) Last Name Title Mr. Mrs. Ms. Dr. Prof. Other (Please circle one) Date of Birth Economy Position Organization Address Beneficiary City Zip Code Country Phone Fax Travel Fund +country code-zone code-tel. No. #Ext. +country code-zone code-fax No. I would like to apply APEC FUND. (APEC travel-eligible economies) No, I do not need to apply any fund. Dietary General Vegetarian Other (please specify) Arrival Information Date Flight No. Departure Information Date Flight No. Time Time Note: Please kindly advise the chief officials or senior reviewers from regulatory authorities to attend. Please remember to advise your flight schedule for better arrangement! The beneficiary provided is for the insurance covered during the whole conference. Please your registration form to the Conference Secretariat Ms. Amanda YEH before August 26 at amandayeh@mpat.org.tw

14 2011 APEC Good Review Practice Workshop on Medical Products Participation First Name Registration Form for Non-Authority Representatives *Please fill in the registration form with CAPITAL LETTERS. October 15 Only (Joint the 9 th Conference of APEC Network on Pharmaceutical Regulatory Science) Last Name Title Mr. Mrs. Ms. Dr. Prof. Other (Please circle one) Date of Birth Economy Position Company Address Beneficiary City Zip Code Country Phone Fax +country code-zone code-tel. No. #Ext. +country code-zone code-fax No. Dietary General Vegetarian Other (please specify) Note: Non-Authority Representatives are welcomed to attend this workshop on October 15 which is the only day open to the public. Attendees may register online at Please book accommodation hotel for your industry representatives through hotel website: No lodging will be assigned to industry representatives by the Conference Secretariat. Please refer to ANNEX D for airport transportation information. The beneficiary provided is for the insurance covered during workshop on October 15. Please your registration form to Conference Secretariat Ms. Amanda YEH before August 26 at amandayeh@mpat.org.tw

15 Annex B 2011 APEC Good Review Practice Workshop on Medical Products Hotel Reservation Form for APEC Economy Authorities and Stakeholders *Please fill in the registration form with CAPITAL LETTERS. Residence Information Passport NO. Title (Please circle one) Mr. Mrs. Ms. Dr. Prof. Other First Name Middle Name Last Name Phone Fax Company Address (including zip code) Mailing Address (including zip code) Accompanying(s) Mr. Mrs. Ms. Dr. Prof. Other First Name Middle Name Last Name Special Room Rate (Including 5% tax, 10% service charge and free breakfast) The Grand Hotel Tel: Fax: Room Request Single Twin No. of Rooms & Nights Requested Total NTD: Credit Card Information VISA MASTERCARD JCB American Express Check-in Date (mm-dd-yyyy) Room Fare: Single/ NTD 5,740 Twin / NTD 6,190 Rooms / Nights Card Number Card Holder s Name Expiry Date Issued Numbers/Security Codes Arrival Information Check-out Date (mm-dd-yyyy) Please your reservation form to the Secretariat Ms. Amanda YEH at amandayeh@mpat.org.tw with your registration form before August

16 Annex C Terminal 1, 1 st floor Map of Taoyuan International Airport Terminal 2, 1st floor For more information, please see

17 Annex D Transportation Information Buses from Tauyuan Airport to The Grand Hotel Buses 1. Where to buy bus tickets: Taoyuan Bus Corporation: Fare paid on the bus. Other buses: Ticket counters are located in the Arrival Passenger Reception Areas of both Terminals. 2. Terminal 1 Bus Platform: On the southwest side of the Arrival Passenger Reception Area. 3. Reception Area. Terminal 2 Bus Platform: On the northeast side of the Arrival Passenger Reception

18 Taxi from Tauyuan Airport to The Grand Hotel Taxis Airport taxis queue outside the arrival halls of both terminals, T1 and T2. To ensure the safety of passengers, only the taxis approved by the Aviation Police Bureau are permitted to operate in the Taoyuan International Airport. Service Hours: 24 hours a day. Fare: Taxi fare is based on the meter plus a 15% surcharge (highway tolls not included). Airport taxis transport passengers to everywhere in Taiwan. (A typical taxi fare to Taipei is approx. NT$1,000~ NT$1400.) TEL: For further information about Terminal 1 Taxis, please call For further information about Terminal 2 Taxis, please call To report a complaint about airport taxi service, please call or

19 Taxi Guarding Card 2011 APEC Good Review Practice Workshop on Medical Products Venue: Chang Yung-Fa Foundation Date: Oct 11-15, 2011 Please take me to The Grand Hotel Thank you! Add: No. 1, Sec 4, Zhongshan N. Rd, Zhongshan Dist., Taipei City, Tel: 請你載我到圓山飯店, 謝謝! 地址 : 台北市中山北路 4 段 1 號電話 :

20 Map around International Convention Center, Chang Yung-Fa Foundation Map around the Grand Hotel

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