TGA international training policy statement
December 2007
The TGA, as a centre of excellence in the evaluation and regulation of medicines and medical devices, is frequently asked to provide training for staff of organisations from various countries in the Asia-Pacific region and beyond. These organisations include government regulatory agencies, regulatory centres and others such as the World Health Organization (WHO).
The training activities are mainly conducted at the TGA in Canberra, Australia, although some programs have been delivered in overseas countries. The programs generally focus on regulation of prescription, over-the-counter and complementary medicines, blood and biological products, and medical devices. The TGA's training activities have been well received in the past by participants and their organisations.
The TGA will continue to provide training activities and technical assistance to overseas regulatory agencies in the region. However, in order to meet the increasing demand and still fulfil its primary responsibility as Australia's regulatory agency for therapeutic goods, the TGA continues to reconsider the way in which the training programs are delivered.
International training calendar
The TGA has developed its 2008 International Training Calendar <http://www.tga.gov.au/international/inttrain.htm> (the Calendar) which is published on the TGA website.
The Calendar provides training opportunities based on the programs most frequently requested by overseas regulatory agencies in recent years and on the feedback received from former participants.
The Calendar is intended to assist regulatory agencies to identify the programs that most meet their need to maximise the learning experience for their staff. Intending participants and their agencies are encouraged to use the Calendar rather than make ad hoc requests to the TGA.
The training activities in the Calendar may be delivered as classroom lectures, workshops, hands-on laboratory work, on-the-job experience or on-site good manufacturing practice (GMP) auditing.
Please note that the training activities in the Calendar are open to officers of overseas government regulatory agencies only.
Meeting the cost of training
The TGA is required to recover 100% of its operating costs. It must therefore fully recover the costs of any training activities it offers and training fees have been calculated accordingly. Training fees for participants who receive financial sponsorship from international bodies such as the World Health Organization or the Drug Information Association will be negotiated. Financial assistance may also be available to participants from certain countries through AusAID (the government agency which oversights Australia's overseas aid program). AusAID may be contacted on +61 2 6206 4000, or at www.ausaid.gov.au.
Applicants should note that, unless otherwise advised, TGA training fees do not cover the costs of the trainee's international travel to Canberra, accommodation in Canberra and other living expenses (including your meals) in Australia. All such costs will need to be met by course participants, who will also be responsible for making their own travel arrangements to attend training courses.
If the total enrollment exceeds the minimum number required for a training activity, a discount of 10% training fee may be offered for each participant from the same agency when there are multiple enrollments.
Numbers of participants in training activities
In order to ensure training is conducted at optimum efficiency, each training activity will have a minimum and maximum number of participants. Please note that if the minimum number of expected participants is not met, the proposed activity may be postponed or cancelled. To avoid this, intending participants are encouraged to submit their applications at the earliest possible date.
If applications received exceed the maximum number of places available in a training activity, the TGA will maintain a "waiting list" of unsuccessful applicants who may be invited to fill any vacancies resulting from withdrawals. Depending on the demand, another similar training activity may be scheduled for later in the year.
Language requirements
As English is the official language for all TGA training activities, a minimum requirement for English proficiency must be met. Please refer to section 5 of the Activity Application Form for more details. The TGA is unable to provide interpreter services or to provide translations of documents in languages other than English.
Applying to participate in a TGA training activity
People who are interested in one or more activities in the Calendar should complete the Activity Application Form attached and return the form to the TGA Training Calendar Coordinator via email (tga.international@tga.gov.au) or fax (+61 2 6232 8535).
Please download the Activity Application Form from the TGA website <http://www.tga.gov.au/international/inttrain.htm#form> and complete the Form on your computer. If you have to complete the Form with hand writing, please write clearly. The completed Form can be either emailed or faxed to the TGA.
The closing date for each activity is indicated in the Calendar, and is generally at least two months prior to the scheduled commencing date. This is to allow sufficient time to notify applicants of their acceptance and for the necessary travel arrangements to be made. Late applications will usually not be considered. The TGA will notify successful applicants within ten working days of the closing date for applications, and will request payment of fees.
Visa application and travel arrangements
Applicants should note, it is your responsibility to ensure that your travel documents (eg. a valid passport, flight itinerary and supporting letters from your own government) are up to date and meet the requirement for Australian visa applications.
If any applicants are unsure about your visa application requirements, you are advised to contact the Australian High Commission/Embassy in your country. Alternatively, applicants could visit the website of the Australian Department of Immigration and Multicultural and Indigenous Affairs <http://www.immi.gov.au>. The TGA may be able to assist participants' applications for Australian visas by issuing letters of invitation to attend courses. This can only be done after the training course application has been lodged and accepted.
In general, a visa application may take 2 weeks or more to process. Therefore potential participants are advised to lodge their visa applications as early as possible and at least 2 weeks prior to the scheduled travelling date. Please be aware that the TGA is not able to request the Australian High Commission/Embassy to give priority consideration to processing your visa in the event you have lodged your visa application late.
Please note, flight bookings for your international travel between your home country and Australia should be made as early as possible, especially during high seasons.
The TGA may be able to assist training activity participants in finding suitable accommodation in Canberra, and applicants should indicate whether they require assistance of this sort.
Payment of training fees
All training fees must be paid in advance to the TGA in Australian dollars, and must be received by the TGA not less than three weeks prior to the commencement of the training activity. If an accepted applicant has not paid fees by the due date, the TGA reserves the right to regard the application as having been withdrawn and to offer the place to another applicant.
The preferred method of payment of the training fee is by bank cheque (bank draft) in favor of the "Therapeutic Goods Administration". Payments can also be made by direct deposit (bank transfer) to the TGA's bank account. However, the funds to be transferred to the TGA must be from the bank account of the trainee's organisation. Payment from a third party direct to the TGA on behalf of the trainee(s) is not acceptable. The training fees can also be paid by a suitable credit card (eg. Visa or Master card). Please contact the TGA training coordinator for more details if you wish to use direct bank transfer or credit card payment.
Training fees quoted include GST (Australian Goods and Services Tax) at 10%.
Cancellation or changes to training activities by the TGA
The TGA reserves the right to postpone, cancel or revise any activity proposed in the Calendar without notice.
If a training activity is cancelled or postponed, the TGA will notify applicants within ten working days of the closing date for applications for the activity. Generally a training activity will be cancelled only if the minimum number of participants has not enrolled in the activity.
If a training activity is cancelled because there are insufficient enrolments or for any other reason, any training fees received by the TGA will be refunded. The same policy will apply if the TGA changes the date of a training activity so that an applicant is no longer able to attend, or changes the content of a training activity so that it is no longer relevant to an applicant.
Withdrawal from a training activity by an applicant
Withdrawals received by the TGA up to three weeks prior to the scheduled commencement of a training activity are refundable, minus a 10% registration service fee. After that, cancellations are subject to the entire fee. Please note that if a participant does not cancel and does not attend, the participant's agency will still be responsible for payment of the fee. Substitutions may be made at any time.
Further information
For further information regarding the 2008 TGA International Training Calendar activities <http://www.tga.gov.au/international/inttrain.htm>, please contact the TGA Training Calendar Coordinator:
Dr Cheng L Bai
Telephone: + 61 2 6232 8585
Fax: + 61 2 6232 8535
Email: tga.international@tga.gov.au