All comments may be sent at [email protected] with the following Subject Format:
*Comments_FC on Conduct of FDA Trainings and Seminars
Deadline of Submission is until 24 May 2023
I. INTRODUCTION
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 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.
With the issuance of the Guidelines on the Nationwide Implementation of the Alert Level System for Covid-19 Response as of 27 February 2022, the Department of Health (DOH) has issued Department Memorandum No. 2022-0127 entitled Resumption of Face to Face and Walk-In Transactions and Activities Related to Learning and Development.
As health restrictions due to Covid-19 ease and the new normal setting is gradually being adopted, the FDA Academy is resuming the conduct of face-to-face learning modality in its continuous service to its external stakeholders in addition to providing online training and seminar.
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 the external stakeholders.
II. OBJECTIVES
A. General Objective
This Circular aims to provide guidance on the conduct of the FDA Academy offered trainings and seminars through online or face-to-face learning mode for external stakeholders.
B. Specific
1. To communicate the health regulatory policies of the FDA to concerned participants through face-to-face and online learning mode;
2. To facilitate trainings and seminars that enhances 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;
4. To serve as an avenue for the clarifications and concerns of the external stakeholders on matters related to the FDA health regulatory policies;
III. SCOPE
This issuance shall cover and apply to all external stakeholders transacting business with the FDA 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 the trainings and seminars offered by the FDA Academy.
IV. DEFINITION OF TERMS
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 instruction.
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, individuals who are interested to avail of the trainings and seminars offered by the FDA Academy.
C. Face-to-Face Learning – a traditional type of learning method where the participants are convened in one venue and topics are discussed directly by the Resource Speaker/s
D. FDA Academy – provider of trainings and seminars for the external stakeholders of the FDA in furtherance of its mandate.
E. FDA Licensing Seminar – this discusses the guidelines on the unified licensing requirements and procedures of the FDA.
F. Free webinar – online training/seminar program that is offered at no cost to the participants.
G. Live webinar – online training/seminar program that is conducted in real-time and to a live audience.
H. Online Training/Seminar – trainings/seminars conducted through internet based/online video-conferencing platforms.
I. Pre-recorded webinar – a previously recorded webinar video that can be viewed or accessed at any given time by interested participants.
J. Registration Fee – refers to the amount paid for the voluntary enrollment of an applicant to a specific training/seminar offered by the FDA Academy, and which is determined based on existing guidelines issued by the government.
K. 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.
IV. GENERAL GUIDELINES
A. 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 at the FDA website and/or its official Facebook page.
B. Participation on the trainings and seminars offered by the FDA Academy is on a voluntary basis.
C. Trainings and seminars may be cancelled, subject to prior notice, by the FDA Academy such as not meeting the required number of participants, unavailability of the Resource Speaker, loss or weak internet connection, power failure or other force majeure reasons.
D. Only the registered email address of the participant who has successfully registered to the program shall be used for all training and seminar related transactions.
E. The FDA Academy shall provide the venue and complimentary meals during the conduct of the training and seminar as part of the registration fee paid by the participants for face-to-face training
V. SPECIFIC GUIDELINES
1. Training and Seminar Registration Procedure for Face-to-Face and Online Learning Mode:
a. Registration to the trainings/seminars shall be on a first-come-first-served basis.
b. All interested applicants shall have an official or valid email address, and are required to register and fill out the registration form prior to the conduct of the seminar.
c. Registration shall be closed once the desired number of applicants is reached.
d. All successful registration is non-transferrable. Changing of date is also not allowed.
e. Training and Seminar with Registration Fees Both Face-to-Face and Online Learning Mode:
After the registration:
i. The Course Assessment Slip (CAS) shall be sent to the registered email address of the applicant for the payment of registration fee once the application is approved.
ii. 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.
iii. 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].
Email subject shall follow the below format:
Payment for [TRAINING CODE]_[Last name, First name, Middle Initial of enrollee]
Eg: Payment for TR-FP_Dela Cruz, Juan A.
iv. 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.
v. 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.
f. Free Online Training and Seminar:
i. A confirmation of registration and the webinar rules shall be sent to the registered e-mail address.
ii. Confirmed participants who may not be able to attend on the actual day of the seminar/training shall inform in advance through email the FDA Academy at [email protected] in order for the latter to give the slots to the wait listed participants;
iii. Confirmed participants who failed to attend the training/seminar for no valid reason shall automatically be disqualified from attending the future training/seminars of the FDA Academy that will be rendered free.
iv. FDA Academy shall evaluate the reason of the participant’s absence and has the right to determine whether the stated reason is acceptable or not.
2. Payment of Registration Fee
a. 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.
b. 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.
c. 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.
d. Payment shall be made through:
| BANK | ACCOUNT NAME | ACCOUNT NUMBER |
| Development Bank of the Philippines (DBP) | FDA Academy Trust Fund | 00-0-00291-430-9 |
| Landbank of the Philippines (LBP) via Over the Counter using ONCOLL payment slip | FDA Policy Planning Clearing Account | 0392-2220-81 |
e. Other modes of online payments shall not be acceptable. Payments made other than the abovementioned FDA Bank Accounts shall be deemed non-refundable.
3. Number of Participants
The number of participants shall be pre-determined by the FDA. Registration shall be closed once the desired number of participants is reached.
4. Training/Seminar Certificate
a. Certificate of Completion – shall be issued to the participants who have fulfilled all the training requirements as follows:
i. Filled out the Attendance Form and attended all the sessions of the training program
ii. Answered the Pre-test
iii. Passed the Post-test (obtained at least 75% correct answers out of the total number of questions)
iv. Accomplished and submitted the Program and Speaker/s Evaluation Form
b. Certificate of Participation – shall be issued to the participants who failed to meet the training requirements
c. An e-Certificate shall be issued for online training and seminar which shall be sent to the participant’s registered email address.
5. 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 |
6. 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.
VI. PRE-RECORDED WEBINAR VIDEOS
i. There will be free pre-recorded webinar videos that may be accessed on the DOH Academy E-Learning Platform. The availability of which will be announced through the FDA website, official Facebook page and other social media platform.
ii. Participants must register through the provided registration form and accomplish the pre-test prior to the start of the webinar.
iii. Participants must pay attention to and understand the pre-recorded webinar videos.
iv. Post-test and evaluation form must be duly accomplished and submitted at the end of the webinar session.
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 takes effect immediately until revoked or superseded.