I. INTRODUCTION
The Food and Drug Administration (FDA) through its FDA Academy conducts training programs for its stakeholders on health product regulation based on the provisions of Republic Act 9711 or the Food and Drug Act of 2009, other relevant laws, policies, and protocols the FDA is implementing.
Given the current situation due to Covid-19 pandemic, the conduct of online learning shall continue to be adopted by the Food and Drug Administration – FDA Academy to comply with the existing health protocols and to ensure the safety of the participants as well as the learning providers.
Taking into consideration the need of the stakeholders to be informed of the regulatory updates (policies and other issuances) on health products registered with the FDA, the FDA Academy shall continue to offer health regulatory and technical trainings to all its interested stakeholders through internet-based video-conferencing platforms. Further, it shall collect registration fees on identified training/seminar programs to sustain its operations based on existing guidelines and applicable accounting and auditing rules and regulations.
For a smooth and efficient conduct of online trainings, there is a need to provide guidelines in the attendance and enrollment to the FDA Academy offered trainings/seminars.
II. OBJECTIVES
A. General
This Circular aims to provide guidance on the conduct of the FDA Academy training/seminar programs through internet based video-conferencing platforms.
B. Specific
- To communicate health regulatory policies of the FDA to target audience without the need to physically convene them in one venue;
- To provide cost-efficient and cost-effective training and seminar programs to the external stakeholders of FDA;
- To facilitate online response and clarification on matters related to FDA health regulatory policies; and
- To reach a broader audience from different regions and locality at one particular time.
III. DEFINITION OF TERMS
A. Cost-efficient training/seminar – a learning event that requires less resources/minimal expense to the program organizer and achieves greater output such as reaching greater number of participants and frequent conduct of training/seminar programs, among others.
B.Cost-effective training/seminar – a learning activity offered at a minimal cost to the participant but delivers the intended objectives of the program.
C. FDA Licensing Seminar – this discusses the guidelines on the unified licensing requirements and procedures of the FDA.
D. Free webinar – online training/seminar program that are offered at no cost to the participants.
E. Live webinar – online training/seminar program that is conducted in real-time to a live audience which may or may not require a fee.
F. Technical training/seminar – training/seminar program that provides the needed knowledge, skills, and/or mastery in a specific field to increase technical competence of the participants
G. Pre-recorded webinar – a previously recorded webinar video that can be viewed or accessed at any given time by interested participants from the website of the FDA or DOH Academy.
IV. GENERAL INFORMATION AND 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 official Facebook page.
B. The list of the FDA Academy offered trainings/seminars can be viewed at the FDA website and on the attached Annex A of this circular.
C. Participation on the trainings/seminars offered by the FDA Academy is on a voluntary basis.
D. Trainings/seminars may be cancelled, subject to prior notice, by the FDA Academy for reasons such as non-confirmation of participants, unavailability of the Resource Speaker, loss or weak internet connection, power failure, or other force majeure.
E. Only the registered email address shall be used for all training/seminar related transactions.
F. 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.
G. Training/Seminar Registration Procedure
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- Registration to the trainings/seminars shall be on a first-come-first-served basis.
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- 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 training via the link provided for each seminar.
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- Registration shall be closed once the desired number of applicants is reached.
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- Once registered, this is considered non-transferrable. Changing of date is also not
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- Training/Seminar with registration fee:
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- a. An assessment slip shall be sent to the registered email of the applicant for the payment of registration fee once the application is approved.
- b. The assessment slip has a five (5) working-day validity once sent. Failure to pay within the validity period shall mean automatic cancellation of the application.
- c. After payment, the applicant shall send the scanned copy of receipt and/or assessment slip with 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].
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Email subject shall follow the format:
Payment for [TRAINING CODE]_[Lastname, Firstname, Middle Initial of enrollee]; Eg: Payment for TR-FP_Dela Cruz, Juan A
d. Failure to send the scanned copy of receipt and/or assessment slip within the validity period shall automatically forfeit the applicant’s payment and application.
e. Upon receipt of the payment receipt and/or assessment slip with bank’s validation, a corresponding confirmation and the webinar rules shall be sent to the applicant’s registered email for the details of the training/seminar.
f. The registration shall end five days prior to the event.
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- Training/Seminar that will be rendered free:
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a. A confirmation of registration and the webinar rules shall be sent to the registered e-mail address.
b. 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;
c. Confirmed participants who failed to attend the training/seminar for no valid reason shall automatically be disqualified from attending future training/seminars of the FDA Academy that will be rendered free.
d. 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.
V. PAYMENT OF REGISTRATION FEE
A. The registration fee shall be based on the expenses incurred by the FDA Academy in the organization and delivery of the training/seminar programs through online video conferencing platform.
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 may be made through:
Payment Channel |
Details |
Bank Deposit | Development Bank of the Philippines (DBP)
Account Name: FDA Special Fund Account Number: 0430-013669-030 |
Over-the-Counter
(when available) |
FDA Cashier at Food and Drug Action Center (FDAC), Starmall, Alabang, Muntinlupa City |
VI. 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.
VII. TRAINING REQUIREMENT
- There shall be an online pre-test and post-test during the actual day of training/ seminar;
- A training/seminar program evaluation shall also be required to be accomplished by the registered participant; and
- For live webinar, attendance shall be strictly monitored throughout the duration of the activity.
VIII. CANCELLATION POLICY
The FDA reserves the right to cancel or re-schedule courses within three (3) day notice. In the event of cancellation, all previously paid fees shall automatically be moved to the next available schedule and participants shall be properly and promptly notified.
IX. PRE-RECORDED WEBINAR VIDEOS
A. Pre-recorded videos from the free training/seminars shall be uploaded and may be accessed from the FDA website and/or DOH Academy. The availability of which will be announced through the FDA website and official Facebook page.
B. Participants must register through the provided registration form and accomplish the pre-test prior to the start of the webinar.
C. A post-test and an evaluation form shall be duly accomplished and submitted at the end of the webinar session so that participants are expected to comprehend the contents of the webinar.
X. CERTIFICATE OF COMPLETION
A. An e-Certificate of Completion shall be issued to the participants of training/seminar programs who have fulfilled all the requirements of the activity, while an e-Certificate of Appearance shall be issued for those who failed to meet all the requirements. E-Certificates shall be sent to the participant’s registered email address.
B. Issuance of the e-Certificates shall be as follows:
Webinar type |
Issuance of e-Certificate |
Pre-recorded webinar available at the DOH Academy and/or FDA website | auto-generated |
Live webinar conducted by the
FDA Academy |
two (2) weeks from the date of the conducted webinar |
XI.EFFECTIVITY
This Circular takes effect immediately until revoked or superseded.
ANNEX A
LIST OF FDA ACADEMY OFFERED TRAINING/SEMINAR PROGRAM THROUGH ONLINE VIDEO-CONFERENCING PLATFORM
The FDA Academy may include additional program as the need arises or as determined by the FDA.
Training/ Seminar Title |
Program Description | Tentative
Duration |
Target Participants | Training Code | Registration Fee |
Center for Cosmetics Household/Urban Hazardous Substances Regulation and Research (CCHUHSRR) | |||||
Licensing Seminar for Cosmetics, Toys and Child Care Articles (TCCA), and Household Urban Pesticide (HUP) Establishment | The programs provides a procedural discussion on the licensing application process and regulatory requirements for cosmetics, TCCA and HUP establishments | 4 hours | Company representatives/ regulatory affairs personnel/ liaison officers and/or company owners of Cosmetics, TCCA and HUP businesses transacting with the FDA and other external stakeholders | LS-CTCCAHUP | Free |
Licensing Seminar for Household/Urban Hazardous Substances (HUHS) Establishment | The programs provides a procedural discussion on the licensing application process and regulatory requirements for Household/Urban Hazardous Substances establishments | 4 hours | Company representatives/ regulatory affairs personnel/ liaison officers and/or company owners of HUHS Businesses transacting with the FDA and other external stakeholders
|
LS-HUHS | Free |
Licensing Seminar for Vapor Products and Heated Tobacco Products Establishment | The programs provides a procedural discussion on the licensing application process and regulatory requirements for Vapor Products and Heated Tobacco Establishments | 4 hours | Company representatives/ regulatory affairs personnel/ liaison officers and/or company owners of VP and HTP Businesses transacting with the FDA and other external stakeholders
|
LS-VP and HTP | Free |
13 ASEAN Modules for Good Manufacturing Practices for Cosmetic Manufacturers and Traders | The program provides a detailed discussion on FDA’s implementation of the 13 ASEAN GMP Training Modules for Cosmetic Manufacturers and Traders | 2 days
(4hr/ session) |
Company representatives/ regulatory affairs personnel/ liaison officers and/or company owners of Cosmetic Businesses transacting with the FDA and other external stakeholders
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13 ASEAN GMP-CMT | To be announced
(TBA) |
Seminar on Technical Requirements and Regulatory Guidelines for Cosmetic Product | The program provides a detailed and procedural discussion on the technical requirements and process for cosmetic product notification
|
2 days
(4hr/ session) |
Company representatives/ regulatory affairs personnel/ liaison officers and/or company owners of Cosmetic Businesses transacting with the FDA and other external stakeholders | TR-RGCP | TBA |
Seminar on Technical Requirement and Regulatory Guidelines for Household Urban and Hazardous Substances (HUHS) Product
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The program provides a detailed and procedural discussion on the technical registration requirements and process for HUHS product registration
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2 days
(4hr/ session) |
Company representatives/ regulatory affairs personnel/ liaison officers and/or company owners of HUHS Businesses transacting with the FDA and other external stakeholders | TR-HUHSP | TBA |
Seminar on Technical Requirement and Regulatory Guidelines for Household/Urban Pesticides (HUP) Product | The program provides a detailed and procedural discussion on the technical registration requirements and process for HUP product registration
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2 days
(4hr/ session) |
Company representatives/ regulatory affairs personnel/ liaison officers and/or company owners of HUP Businesses transacting with the FDA and other external stakeholders | TR-HUPP | TBA |
Seminar on Technical Requirements and Regulatory Guidelines for Toys and Childcare Articles (TCCA) Product | The program provides a detailed and procedural discussion on the technical requirements and process for toys and childcare articles product notification
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4 hours | Company representatives/ regulatory affairs personnel/ liaison officers and/or company owners of TCCA Businesses transacting with the FDA and other external stakeholders | TR-TCCAP | TBA |
Seminar on Technical Requirements and Regulatory Guidelines for Vapor Product and Heated Tobacco Product | The program provides a detailed and procedural discussion on the technical registration requirements and process for VP and HTP product registration
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1 day | Company representatives/ regulatory affairs personnel/ liaison officers and/or company owners of VP and HTP Businesses transacting with the FDA and other external stakeholders
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TR-VPHTPP | TBA |
Pest Control Operators and Applicators (PCO and PCA) Certification Seminar | The program provides a detailed and procedural discussion on the technical requirements and process for the certification establishments
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5 days
(4hr/ session) |
Company representatives/ regulatory affairs personnel/ liaison officers and/or company owners of PCO and PCA Businesses transacting with the FDA and other external stakeholders
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PCOA | TBA |
Seminar on Globally Harmonized System of Classification and Labelling of Chemicals (GHS) for HUHS Product | The program provides an in-depth discussion of the GHS and its application on FDA-CCRR-regulated products
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3 days
(4hr/ session) |
Company representatives/ regulatory affairs personnel/ liaison officers and/or company owners of HUHS Businesses transacting with the FDA and other external stakeholders
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GHS-HUHS | TBA |
Seminar on Manufacturing Guidelines for VP and HTP Manufacturers and Traders | The program provides a detailed discussion on FDA’s minimum guidelines on manufacturing practices on VPs and HTPs
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2 days
(4hr/ session) |
Company representatives/ regulatory affairs personnel/ liaison officers and/or company owners of VP and HTP Businesses transacting with the FDA and other external stakeholders | MG-VPHTPMT | TBA |
Seminar on Good Distribution and Storage Practices Guidelines for Vapor Products and Heated Tobacco Product Distributors and Retailers | The program provides a detailed discussion on FDA’s minimum guidelines on storage and distribution practices on vapor products and heated tobacco products
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4 hours | Company representatives/ regulatory affairs personnel/ liaison officers and/or company owners of VP and HTP Businesses transacting with the FDA and other external stakeholders
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GDSPVPHTPDR | TBA |
Center for Drug Regulation and Research (CDRR) | |||||
Licensing Seminar for Drug Outlets | The programs provides a procedural discussion on the licensing application process and regulatory requirements for drug outlets | 4 hours | Drug outlets owners, Pharmacists, Pharmacy Assistants and Other External Stakeholders
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LS-DO | Free |
Seminar on the Regulation of Veterinary Medicines | The program aims to provide procedural discussion on the regulatory requirements for veterinary medicines | 3 hours | Veterinary Products Stakeholders
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RVM | TBA |
Seminar on the Regulation of Veterinary Medicines – Animal Vaccines
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The program aims to provide procedural discussion on the regulatory requirements for veterinary medicines – Animal Vaccines
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2 hours | Veterinary Products Stakeholders
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RVM-AV | TBA |
Introduction to Pharmaceutical Product Registration
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The program aims to provide an introduction and procedural discussion on the regulatory requirements of pharmaceutical products for human use | 3 hours | Pharmaceutical product for human use stakeholders
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IPPR | TBA |
Seminar on the Pharmaceutical Product Registration – Stability Guideline
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The program aims to provide a discussion on the stability guidelines as used in product registration
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2 hours | Pharmaceutical product for human use stakeholders | PPRSG | TBA |
Pharmacovigilance 101
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The program aims to provide a discussion on how pharmacovigilance is done and its important role in ensuring the QSE of pharmaceutical products
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2 hours | Qualified Persons for Pharmacovigilance of the Pharmaceutical Industry
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PV | TBA |
Seminar on the Pharmaceutical Product Registration – Bioavailability/Bioequivalence (BA/BE) Guidelines
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The program aims to provide a discussion on the Bioavailability/Bioequivalence (BA/BE) guidelines used in product registration
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2 hours | Pharmaceutical product for human use stakeholders | PPRBABEG | TBA |
Seminar on the Pharmaceutical Product Registration – Labelling Guidelines and Its Relationship to Ads and Promo
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The program aims to provide a discussion on the labelling guidelines and its relationship to Ads and Promo
|
2 hours | Pharmaceutical product for human use stakeholders | PPRLGRAP | TBA |
Center for Device Regulation, Radiation Health, and Research (CDRRHR) | |||||
Seminar on Licensing of Medical Device Establishment for Distributors | The programs provides a procedural discussion on the licensing application process and regulatory requirements for medical device establishments for Distributors | 4 hours | Medical Device Distributors: • Importers • Wholesalers • Retailers • Exporters and other External Stakeholders
|
LS-MDD | Free |
Seminar on Technical Requirements and Regulatory Guidelines for Medical Device Product
|
The program provides a detailed and procedural discussion on the technical requirements and process for medical device product registration | 1 day | Medical Device Industry • Importers • Manufacturers and other external stakeholders
|
TR-RGMDP | TBA |
Seminar on Medical Device Classification
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The program provides information on the classification of medical devices based on the ASEAN Harmonized Rule. Topic on Classification Rule for IVD’s is included. | 3 hours | Medical Device Industry • Importers • Manufacturers and other external stakeholders
|
MDC | TBA |
Center Food Regulation Research | |||||
Licensing Seminar for Food Establishments
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The programs provides a procedural discussion on the licensing application process and regulatory requirements for food establishment. | 3 hours | Company representatives/ regulatory affairs personnel/ liaison officers and/or company owners of Food Businesses transacting with the FDA
|
LS-F | Free |
Seminar on Technical Requirements and Procedures for E-Registration of All Pre-Packaged, Processed Food Product | The program provides discussion on technical registration requirements and E-Registration procedure for prepackaged, processed food products | 3 hours | Company representatives/ regulatory affairs personnel/ liaison officers and/or company owners of Food Businesses transacting with the FDA and other external stakeholders
|
TR-FP | TBA |
Overview of the Philippine Mandatory Labelling Guidelines | The program provides discussion on the labeling guidelines as stipulated in Administrative Order 2014-0030 and other issuances related to labeling of prepackaged, processed food products and food supplements | 3 hours | Company representatives/ regulatory affairs personnel/ liaison officers and/or company owners of Food Businesses transacting with the FDA | PMLG | TBA |
Seminar on Guidelines on Advertisement and Sales Promotion and Securing BOC Clearance | The program provides discussion on the requirements in securing Ads and Sales Promotion Permit, and in securing BOC Clearance for various purposes for products under the Center for Food Regulation | 2 hours | Company representatives/ regulatory affairs personnel/ liaison officers and/or company owners of Food Businesses transacting with the FDA; ads and marketing agencies
|
GASPSBC | TBA |
Overview of the IRR of Food Safety Act 2013 And Post Marketing Surveillance Activities of CFRR | The programs provides an overview of the Food Safety Act of 2013 and a brief lecture on the post marketing surveillance activities for processed food products. An overview of the procedures on handling complaints reported to Center for Food Regulation and Research will also be presented. | 3 hours | Company representatives/ regulatory affairs personnel/ liaison officers and/or company owners of Food Businesses transacting with the FDA
|
FSA and PMS | TBA |