FDA Circular No. 2017-012

Training Courses/Seminars and Schedule of Fees for Regional Licensing Seminar for Drugstores and Outlets (LSD-O) Offered by the Food and Drug Administration (FDA) Academy – Policy and Planning Service (PPS) for Calendar Year 2017

I. BACKGROUND

As part of its continuous service, the Food and Drug Administration established the FDA Academy to provide access to relevant and effective training. The conduct of such trainings ensures proper dissemination of policies, procedures and guidelines implemented by FDA in the exercise of its regulatory powers. FDA Academy trainings are designed to ensure that the industry representatives or Qualified Persons in Industry Regulatory Affairs (QPIRA) nominated by regulated establishments demonstrate competence and professionalism in preparing and submitting correct and complete applications.

2. SCOPE AND PURPOSE

This Circular aims to provide the schedules of the Regional Licensing Seminar for Drugstores and Outlets (LSD-O) to be held by the FDA Academy – PPS for Calendar Year 2017, and the corresponding schedule of fees.

3. DETAILS

The licensing seminar for drugstores and outlets is a one-day training intended for pharmacists. A series of lectures are provided to discuss on significant aspects of drugstore and outlet operations, with reference to rules and regulations implemented by FDA through the Center for Drug Regulation and Research.

These lectures are designed to cover topics on: FDA Application Process, Licensing Process and Requirements, Good Distribution and Storage Practice, Cold Chain Management, Good Dispensing Practice, Risk Management Plan, Counterfeit Monitoring, Product Recall, Pharmacovigilance and FDA Adverse Events Reporting.

3.1COURSE SCHEDULES AND FEES

The FDA Academy shall offer the following regional LS-DOs for a fee on the dates specified:

Date

Location

Course Code

Course Fee

9 November 2017

Cebu City, Cebu

LSD-O (VC)

₱ 3,000.00

23 November 2017

Davao City, Davao

LSD-O (ME)

₱ 3,000.00

7 December 2017

Baguio City, Benguet

LSD-O (NL)

₱ 3,000.00

13 December 2017

Legazpi City, Bicol

LSD-O (SL)

₱ 3,000.00

19 December 2017

General Santos City, South Cotabato

LSD-O (MW)

₱ 3,000.00

3.2REGISTRATION PROCEDURE AND PAYMENT

Registration is accommodated on a first-come, first-served basis. The registration procedure may be found at www.fda.gov.ph (Industry Corner – Downloadables – FDA Academy Forms).

Payment can be made over-the-counter (FDA Cashier Room 106, FDA Regional Field Office Cashier) or thru Development Bank of the Philippines (DBP) Branches, Account name: FDA Special Fund and Account number: 0430-013669-030. For guidance, interested parties are further advised to refer to FDA Circular No. 2017-010 for the Updated Collection Policy and Procedure.

3.3 TRAINING ACTIVITY DETAILS

All training courses start at 8:00 AM and will finish at 5:00 PM (FDA MC No. 2013-016). FDA reserves the right to cancel or re-schedule training courses within three (3) days’ notice (FDA MC No. 2013-043). In the event of such cancellation, the training activity shall be re-scheduled within the year and the participants shall be properly notified. Likewise, if the need arises, FDA Academy may provide additional training courses for the concerned stakeholders and government agencies

Under this Order, expenses that will be incurred for food, venue, training kits/supplies, transportation, per diem and other miscellaneous expenses that shall be charged against the FDA Special Fund Account, subject to usual accounting and auditing rules and regulations.

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