The Policy and Planning Service – FDA Academy announces the following seminar/training offerings for the 1st Semester of CY 2024 through online video-conferencing platform, and may include additional program as the need arises:
MARCH2024
| Title of Training/Seminar |
Center Responsible
|
Program Description | Schedule | Course
Code |
Registration
Fee |
| Licensing Seminar for Drug Establishments | Center for Drug Regulation and Research (CDRR)
|
A licensing seminar for FDA Center for Drug Regulation and Research stakeholders which aims to provide information on the Rules and Regulations prescribing the requirements and procedures in the application for License to Operate for drug manufacturers, repackers, traders, distributors, importers, exporters and wholesalers, drug outlets, CROs and sponsors. The topics include the requirements, procedure for Eportal and Eservices Portal Systems covering the initial, renewal and variation applications; as well as the schedule of fees and processing time. | 06 March 2024 | LS-D
|
FREE |
| Webinar on Technical Requirements and Regulatory Guidelines in Toys and Child Care Articles Products | Center for Cosmetics and Household/
Urban Hazardous Substances Regulation and Research (CCHUHSRR) |
The program provides detailed discussions on the technical requirements and procedure for the issuance of Certificate of Product Notification for TCCA products. | 13 March 2024 | TR-TCCAP
|
Php 500.00 |
| Licensing Seminar for Cosmetics, Toys and Childcare Articles (TCCA), and Household/Urban Pesticide (HUP) Establishments | Center for Cosmetics and Household/
Urban Hazardous Substances Regulation and Research (CCHUHSRR) |
This seminar is intended for all Cosmetics, Toys and Childcare Articles (TCCA), and Household/Urban Pesticide (HUP) distributors, traders, and manufacturers.
The aim of this seminar is to gain knowledge on the implementing guidelines of A.O. No. 2020-0017 on the Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration.
Topics include Types of establishments, LTO requirements, documents needed upon inspection, and the e-LTO system process. |
14 March 2024 | LS-CTCCAHUP
|
FREE |
| Licensing Seminar for Food Establishments | Center for Food Regulation and Research (CFRR) | A licensing seminar for FDA Center for Food Regulation and Research stakeholders which aims to provide information on the Rules and Regulations prescribing the requirements and procedures in the application for License to Operate for food manufacturers, repackers, traders, distributors, importers, exporters and wholesaler. The topics include the requirements, procedure for Eportal and Eservices Portal Systems covering the initial, renewal and variation applications; as well as the schedule of fees and processing time. | 20 March 2024 | LS-F
|
FREE |
| Licensing Seminar for Household/Urban Hazardous Substances (HUHS) Establishments | Center for Cosmetics and Household/
Urban Hazardous Substances Regulation and Research (CCHUHSRR) |
This seminar is intended for all Household/Urban Hazardous Substances (HUHS) distributors, traders, and manufacturers.
The aim of this seminar is to gain knowledge on the implementing guidelines of A.O. No. 2019-0019: Reinstatement of Requirements of Licensing as Importers, Exporters, Manufacturers, Toll Manufacturers, Wholesalers, Distributors, Retailers, or Re-Packers of those Engaged in Certain Household/Urban Hazardous Substances, and from the Requirement of Prior Registration and/or Notification of Said Products.
Topics include Regulated HUHS products, Types of establishments, LTO requirements, General and Specific guidelines, and ePortal V2 walkthrough. |
21 March 2024 | LS-HUHS
|
FREE |
APRIL 2024
| Title of Training/Seminar |
Center Responsible
|
Program Description | Schedule | Course
Code |
Registration
Fee |
| Licensing Seminar for Medical Device Establishments | Center for Device Regulation, Radiation Health and Research (CDRRHR) | A licensing seminar for FDA Center for Device Regulation, Radiation Health, and Research stakeholders which aims to provide information on the Rules and Regulations prescribing the requirements and procedures in the application for License to Operate for medical device manufacturers, repackers, traders, distributors, importers, exporters and wholesaler. The topics include the requirements, procedure for Eportal and Eservices Portal Systems covering the initial, renewal and variation applications; as well as the schedule of fees and processing time. | 03 April 2024 | LS-MD | FREE |
| Licensing Seminar for Pest Control Operator (PCO) Establishments | Center for Cosmetics and Household/
Urban Hazardous Substances Regulation and Research (CCHUHSRR) |
This seminar is intended for all Pest Control Operators (PCO) engaged in the application of household/urban pesticides (HUP) or any other methods/services for pest control. Participants may be owners/ general managers/ authorized representatives of PCO establishments, as well as supervising pesticide handlers, and pesticide handlers.
The aim of this training is to gain knowledge on the implementing guidelines of DOH A.O. No. 2019-0010 on the Issuance of a License to Operate (LTO) as a Household/Urban Pest Control Operator.
Topics include LTO requirements, demonstration of LTO application as a PCO establishment via the FDA eServices Portal, inspection requirements and responsibilities of PCO establishments, supervising pesticide handlers, and pesticide handlers among others. |
11 April 2024 | LS-PCO | FREE |
| Webinar on Good Distribution and Storage Practice for Medical Products (For Drug Distributors) | Field Regulatory Operations Office (FROO) | The program will provide an introduction and give an update to the pharmaceutical industry on Good Distribution Practice and Good Storage Practice as well as their roles in ensuring the safety of pharmaceutical products during transport and storage. | 29 April 2024 | GDSPMP-DD | Php 500.00 |
| Webinar on Good Dispensing and Storage Practices for Drug Outlets | Field Regulatory Operations Office (FROO) | The program will provide an introduction on Good Dispensing and Storage Practices for Drug Outlets and its role in ensuring the safety of pharmaceutical products during storage until dispensed to consumers. | 30 April 2024 | GDSP-DO | Php 500.00 |
MAY 2024
| Title of Training/Seminar |
Center Responsible
|
Program Description | Schedule | Course
Code |
Registration
Fee |
| Licensing Seminar for Drug Establishments | Center for Drug Regulation and Research (CDRR) | A licensing seminar for FDA Center for Drug Regulation and Research stakeholders which aims to provide information on the Rules and Regulations prescribing the requirements and procedures in the application for License to Operate for drug manufacturers, repackers, traders, distributors, importers, exporters and wholesaler. The topics include the requirements, procedure for Eportal and Eservices Portal Systems covering the initial, renewal and variation applications; as well as the schedule of fees and processing time. | 08 May 2024 | LS-D | FREE |
JUNE 2024
| Title of Training/Seminar |
Center Responsible
|
Program Description | Schedule | Course
Code |
Registration
Fee |
| Licensing Seminar for Cosmetics, Toys and Childcare Articles (TCCA), and Household/Urban Pesticide (HUP) Establishments | Center for Cosmetics and Household/
Urban Hazardous Substances Regulation and Research (CCHUHSRR) |
This seminar is intended for all Cosmetics, Toys and Childcare Articles (TCCA), and Household/Urban Pesticide (HUP) distributors, traders, and manufacturers.
The aim of this seminar is to gain knowledge on the implementing guidelines of A.O. No. 2020-0017 on the Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration.
Topics include Types of establishments, LTO requirements, documents needed upon inspection, and the e-LTO system process. |
04 June 2024 | LS-CTCCAHUP | FREE |
| Licensing Seminar for Food Establishments | Center for Food Regulation and Research (CFRR) | A licensing seminar for FDA Center for Food Regulation and Research stakeholders which aims to provide information on the Rules and Regulations prescribing the requirements and procedures in the application for License to Operate for food manufacturers, repackers, traders, distributors, importers, exporters and wholesaler. The topics include the requirements, procedure for Eportal and Eservices Portal Systems covering the initial, renewal and variation applications; as well as the schedule of fees and processing time. | 05 June 2024 | LS-F | FREE |
| Licensing Seminar for Medical Device Establishments | Center for Device Regulation, Radiation Health and Research (CDRRHR) | A licensing seminar for FDA Center for Device Regulation, Radiation Health, and Research stakeholders which aims to provide information on the Rules and Regulations prescribing the requirements and procedures in the application for License to Operate for medical device manufacturers, repackers, traders, distributors, importers, exporters and wholesaler. The topics include the requirements, procedure for Eportal and Eservices Portal Systems covering the initial, renewal and variation applications; as well as the schedule of fees and processing time. | 26 June 2024 | LS-MD | FREE |
| Licensing Seminar for Household/Urban Hazardous Substances (HUHS) Establishments | Center for Cosmetics and Household/
Urban Hazardous Substances Regulation and Research (CCHUHSRR) |
This seminar is intended for all Household/Urban Hazardous Substances (HUHS) distributors, traders, and manufacturers.
The aim of this seminar is to gain knowledge on the implementing guidelines of A.O. No. 2019-0019: Reinstatement of Requirements of Licensing as Importers, Exporters, Manufacturers, Toll Manufacturers, Wholesalers, Distributors, Retailers, or Re-Packers of those Engaged in Certain Household/Urban Hazardous Substances, and from the Requirement of Prior Registration and/or Notification of Said Products.
Topics include Regulated HUHS products, Types of establishments, LTO requirements, General and Specific guidelines, and ePortal V2 walkthrough. |
28 June 2024 | LS-HUHS | FREE |
Please note that the aforementioned schedule is subject to postponement or change due to the unexpected loss of or weak internet connection, sudden power interruption, unavailability of the Resource Speaker/s, or other force majeure reasons.
All interested stakeholders shall register through the link and QR code to be provided for each seminar/training which shall be posted on the FDA website (www.fda.gov.ph) and official Facebook Page. Registration shall be on a first-come-first-served-basis.
Registered participants shall wait for the email confirmation and Course Assessment Slip (CAS) to be sent by the FDA Academy. Only the registered participants who received the CAS shall proceed to payment following the instructions provided by the FDA Academy.
Payments made without the required registration and CAS shall automatically be forfeited and shall be non-refundable/non-transferable.
For inquiries and other concerns, please call the FDA Academy at telephone number (02) 8877-02-59 or email at [email protected].