I. RATIONALE
The Food and Drug Administration (FDA) through the FDA Academy conducts training programs for its stakeholders on health establishment and product regulations based on the provisions of Republic Act No. 9711 or the “Food and Drug Administration Act of 2009” and other relevant laws. The conduct of such trainings ensures proper dissemination of policies, procedures, and guidelines implemented by the FDA in the exercise of its regulatory powers.
As the training arm of the FDA, the FDA Academy intends to provide training and seminars to a large number of stakeholders. In pursuit of this, the FDA Academy shall provide training and seminars through two learning modes: 1) face-to-face and 2) through online video conferencing platforms. Further, to ease the burden and facilitate the application process of the stakeholders, the FDA Academy shall institutionalize an online registration procedure.
For the efficient and effective delivery of service, this guideline is hereby issued for the conduct of online and face-to-face trainings and seminars offered by the FDA Academy to external stakeholders.
II. OBJECTIVES
This Circular aims to provide guidance on the conduct of the FDA Academy offered trainings for external stakeholders through online or face-to-face learning modes.
1. To communicate the health regulatory policies of the FDA to concerned participants through face-to-face and online learning modes;
2. To facilitate trainings and seminars that enhance the learning experiences of the external stakeholders;
3. To provide opportunities for the external stakeholders to actively engage and participate in the trainings and seminars; and
4. To serve as an avenue for clarifications and concerns of the external stakeholders on matters specific to the FDA health regulatory policy being discussed.
III. SCOPE
This issuance shall cover and apply to all external stakeholders transacting business with the FDA including but not limited to health product establishments, other government agencies, Local Government Units, private entities, Non-Government Organizations, and individuals who are intending to avail of the trainings and seminars offered by the FDA Academy.
IV. DEFINITION OF TERMS
For purposes of this issuance, the following terms are defined and shall be understood as follows:
A. Course Assessment Slip (CAS) – refers to the form issued by the FDA Academy to all successful registrants of a given training/seminar. The CAS contains the necessary information of the registrant, the registration fee, and the payment instructions.
B. External Stakeholders – refers to those transacting business with the FDA including but not limited to health product establishments, other government agencies, Local Government Units, private entities, non-government organizations, and individuals who are interested to avail of the trainings and seminars offered by the FDA Academy.
C. Face-to-Face Learning – a learning method provided in person where the participants and resource speakers are convened in one physical venue.
D. FDA Academy – one of the FDA Offices that provides trainings and seminars to external stakeholders of the FDA in furtherance of its mandate.
E. FDA Licensing Seminar – this discusses the guidelines on the licensing requirements and procedures of the FDA.
F. Online Training/Seminar – training/seminar conducted through internet based/online video-conferencing platforms. It can be live or pre-recorded and offered with a fee or at no cost to the participants.
G. Pre-recorded video – a previously recorded video that can be viewed or accessed via the DOH e-Learning Platform at any given time by interested participants.
H. Registration Fee – refers to the amount paid for the voluntary enrollment to a specific training/seminar offered by the FDA Academy, and which is determined based on existing guidelines issued by the government.
I. Technical Training/Seminar – refers to a specialized training program that provides the required knowledge, skills, and/or mastery in a particular field of study to increase the technical competence of an individual.
V. GENERAL GUIDELINES
A. Collection of registration fees and the use of proceeds from the conduct of trainings/seminars offered by the FDA Academy shall be guided by the General Provisions under the General Appropriation Act (GAA) cited hereunder:
“Departments, bureaus, offices, and instrumentalities of the National Government, including Constitutional Offices enjoying fiscal autonomy which conducts seminar, conference, training, and oath taking programs in relation to their mandated functions are authorized to collect fees from government and private agency participants for said activities. The proceeds derived from each seminar, conference, training, and oath taking activities shall be deposited with the National Treasury as income of the General Fund pursuant to Section 44, Chapter 5, Book VI of E.O. No. 292”.
“However, the agencies which do not have appropriations in their budgets for the purpose may use the proceeds for the conduct of the said seminar, conference, training, and oath-taking activities subject to budgeting, accounting, and auditing rules and regulations. Any excess proceeds shall be deposited with the National Treasury as income of the General Fund”.
B. The schedule of training/seminar programs with the training code, date of conduct, and corresponding registration fee shall be separately issued through an announcement posted on the FDA website and/or its official Facebook page.
C. Participation in the trainings and seminars offered by the FDA Academy is voluntary.
D. Trainings and seminars may be canceled by the FDA Academy with prior notice. The reasons for cancelation may include but are not limited to the lack of participants, unavailability of the resource speaker, loss of internet connection, power failure, or other unforeseeable circumstances.
E. Only the registered e-mail address of the participant who has successfully registered on the program shall be used for all training and seminar-related transactions.
F. The FDA Academy shall provide the venue and meal/snack during the conduct of face-to-face training and seminars as part of the registration fee paid by the participants.
G. The link of the training/seminar shall be dedicated to the participant who has successfully registered to the program. Sharing of the training/seminar link to others is strictly not allowed.
H. Registration to the trainings/seminars shall be on a first-come-first-served basis.
I. Registration shall be closed once the desired number of applicants is reached.
J. All successful registration is non-transferrable. Changing of date is also not allowed.
VI. SPECIFIC GUIDELINES
A. Registration Procedure
1. For Face-to-Face and Online Training Seminar with Fees
a. All interested applicants shall have an official or valid e-mail address, and are required to register and fill out the registration form prior to the conduct of the training/seminar.
b. Accomplished the registration form via the link or QR Code provided on the FDA Website or FDA Official Facebook page.
c. The Course Assessment Slip (CAS) shall be sent to the registered e-mail address of the applicant for the payment of the registration fee once the application is approved. The CAS has a five (5) working day validity once sent. Failure to pay within the validity period shall mean automatic cancellation of the application.
d. After payment, the applicant shall send a clear scanned copy of the proof of payment and CAS with signature and bank’s validation within the five (5) working-day validity period to the FDA Academy via email at [email protected], copy furnished the FDA Cashier at [email protected] and Accounting Division at [email protected].
e. Email subject shall follow the below format:
Payment for [TRAINING CODE]_[Last name, First name, Middle Initial of enrollee]
E.g., Payment for TR-FP_Dela Cruz, Juan A.
f. Upon receipt of the proof of payment and CAS with signature and bank’s validation, a corresponding confirmation shall be sent to the applicant’s registered email for the details of the training/seminar within three (3) working days. Failure to send the scanned copy of the proof of payment and CAS with signature and bank’s validation within the validity period shall automatically forfeit the applicant’s payment and application.
2. For Free Online Training Seminar
a. Accomplished the registration form via the link or QR Code provided on the FDA Website or FDA Official Facebook page.
b. Confirmation of registration and webinar link including the webinar rules shall be sent to the registered e-mail address.
c. Confirmed participants who will not be able to attend the seminar/training shall inform in advance through email the FDA Academy at [email protected]. The vacated slots shall be given to waitlisted applicants for training registration.
d. Confirmed participants who failed to attend the training/seminar without valid reason shall automatically be disqualified from attending future training/seminars of the FDA Academy.
e. FDA Academy shall evaluate the reason for the participant’s absence and determine whether the stated reason is acceptable or not.
f. Post-test and evaluation forms must be duly accomplished and submitted at the end of the webinar session.
B. Payment of Registration Fee
1. The registration fee shall be based on the expenses incurred by the FDA Academy in the organization and the delivery of the online and face-to-face training and seminar programs which cover the venue, food, training kit, training supplies, and materials, the FDA Academy staff and Resource Speakers’ transportation, internet subscription, electricity, imputed cost, and other related expenses.
2. Registration fee must be settled within the validity period of the assessment slip, and is non-transferable and non-refundable. Absence/Non-appearance during the confirmed training dates automatically forfeits the registration fee.
3. Payment made prior to issuance of the CAS and without the required registration shall automatically be forfeited and shall be non-transferable and non-refundable.
4. Payment shall be made through:
|
Type of Training |
Timeline of Issuance of Certificate |
Type of Training |
|
Face-to-Face Training and Seminar |
Right after the completion of the activity |
Face-to-Face Training and Seminar |
5. Payments made through modes or platforms other than the ones listed above shall not be accepted.
C. Number of Participants
The number of participants shall be pre-determined by the FDA Academy. Registration shall be closed once the desired number of participants is reached.
D. Pre-recorded Videos
1. Pre-recorded videos that are free of charge shall be offered to the public through the DOH Academy E-Learning Platform. The availability of these shall be announced through the website, official Facebook page, and other official social media platforms of the FDA.
2. Participants must register through the provided registration form and accomplish the pre-test prior to the start of the webinar.
E. Training/Seminar Certificate
1. Certificate of Completion – shall be issued to the participants who have fulfilled all the training requirements as follows:
a. Filled out the Attendance Form and attended all the sessions of the training program
b. Answered the Pre-test
c. Passed the Post-test (obtained at least 75% correct answers out of the total number of questions)
d. Accomplished and submitted the Program and Speaker/s Evaluation Form
2. Certificate of Participation – shall be issued to the participants who failed to meet the training requirements
3. An e-Certificate shall be issued for online training and seminar which shall be sent to the participant’s registered email address.
F. Issuance of Certificates shall be as follows:
|
Type of Training |
Timeline of Issuance of Certificate |
|
Face-to-Face Training and Seminar |
Right after the completion of the activity |
| Online Training and Seminar | Fifteen (15) working days after completion of the activity |
| Pre-recorded webinar available on the DOH Academy and/or FDA website |
Auto-generated |
G. Training/Seminar Cancellation
The FDA reserves the right to cancel or re-schedule courses upon prior notice. In the event of cancellation, all previously paid registration fees shall automatically be moved to the next available schedule and participants shall be properly and promptly notified
VII. SEPARABILITY CLAUSE
In case any section or provision of this Circular or any part thereof, or the application of such section, provision, or portion shall be declared invalid, the validity of the remaining provisions of this Circular shall not in any way be affected or impaired thereby.
VIII. REPEALING CLAUSE
FDA Circular No. 2021-007 entitled “Guidelines on the Attendance/Enrollment to FDA Academy Training/Seminar Programs Offered Through Online Video Conferencing Platform”, and other issuances inconsistent with this Circular are hereby repealed and/or modified accordingly.
IX. EFFECTIVITY
This Circular shall take effect after fifteen (15) days following the publication in the Official Gazette or in a newspaper of general circulation and filing with the Office of the National Administrative Register of the UP Law Center.