COURSE CALENDAR 2016 - QUALIFIED PERSON IN INDUSTRY REGULATORY AFFAIRS (QPIRA) TRAINING ACCREDITATION as per FDA MC. No. 2013-004

FDA ACADEMY
Innovating KNOWLEDGE, Empowering PEOPLE   
COURSE CALENDAR 2016       
QUALIFIED PERSON IN INDUSTRY REGULATORY AFFAIRS (QPIRA) TRAINING ACCREDITATION as per FDA MC. No. 2013-004       
TITLE COURSE DESIGN DATE Course Fee
QPIRA for Center for Food Regulation and Research (QCFRR) A 2-day training-accreditation intended for company liaison officer to become FDA accredited QPIRA for Center for Food Regulation and Research. Aimed at providing information on FDA Application Process, guidance on acquiring market authorizations such as License to Operate (LTO) and Certificate of Product Registration (CPR) from CFRR and Post Marketing Surveillance, Releasing (ICTMD), Fees and Charges. 14-15 April

19-20 May

21-22 July

15-16 September

17-18 November
Php6,000.00
QPIRA for Center for Drug Regulation and Research (QCDRR) Qualified Persons in Industry Regulatory Affairs (QPIRA) trainings is required for Regulatory Officers to officially transact with the FDA. The ASEAN Common Technical Documents/Requirements (ACTD/Rs) for drug products will be the highlight in this 2-day seminar. 7-8 April

14-15 July

13-14 September
Php6,000.00 
QPIRA for Center for Cosmetic  Regulation and Research (QCCRR) A 2-day training-accreditation intended for company liaison officer to become FDA accredited QPIRA for Center for Cosmetics Regulation and Research. Aimed at providing information on FDA Application Process, guidance on acquiring market authorizations such as License to Operate (LTO) and Certificate of Product Registration (CPR) from CCRR and Post Marketing Surveillance, Releasing (ICTMD), Fees and Charges. 19-20 April

14-15 June

16-17 August

11-12 October
Php6,000.00
QQPIRA for Center for Cosmetics Regulation and Research - Household Urban Hazardous Substances including Household/Urban Pesticides and Toys and Child-Care Articles (TCCAs) (QCCRR-HUHS) A 2-day training-accreditation intended for company liaison officer to become FDA accredited QPIRA for Center for Cosmetics Regulation and Research - Household Urban Hazardous Products. Aimed at providing information on FDA Application Process, guidance on acquiring market authorizations such as License to Operate (LTO) and Certificate of Product Registration (CPR) from CCRR-HUHP and Post Marketing Surveillance, Releasing (ICTMD), Fees and Charges. 3-4 May

12-13 July

6-7 September

15-16 November
Php6,000.00
QPIRA for Center for Device Regulation, Radiation Health and Research (QCDRRHR) A 2-day training-accreditation intended for company liaison officer to become FDA accredited QPIRA for Center for Device Regulation, Radiation Health and Research. Required for LTO for Medical Devices and aimed at providing guidance product registration requirements to acquire Marketing Authorization 31 March - 1 April

23-24 June

22-23 September
Php6,000.00
OTHER SEMINAR   
CENTER FOR DRUG REGULATION AND RESEARCH
Pharmacovigilance Regulations and Guidelines for PV Officer Pharmacovigilance is a vital post-marketing activity to ensure the safety, quality, and efficacy of drug products in the market. To strenghten partnerships and to align initiatives, FDA calls on the Pharmacovigilance Officers in the industry to a 2-day seminar workshop regarding the processes and regulations of the regulatory agency's Pharmacovigilance system. 13-14 October Php4,000.00
Licensing Seminar on A.O. 34 for Drugstores and Outlets (LSD-DO) This is a 1-day seminar intended for drugstores or outlets (as defined by AO 2014-034). Good Distribution and Storage Practice (GDSP) will be highlight of this seminar. Regulatory requirements and processes will be discussed along with related post-marketing activities attachedto the License-to-Operate (LTO) as Drugstore/Outlet. 5 May
6 May

1 September
2 September

5 October
6 October
7 October
Php3,000.00
Licensing Seminar on A.O. 34 for Drug Manufacturer and Trader  (LSD-DM) This is a 2-day seminar for drug manufacturers. Regulatory processes in the application for a License-to-Operate (LTO) as Manufacturers will be presented. Good Manufacturing Practices (GMP), the primary requirement for manufacturers will be the highlight in this seminar. Other related topics such as post-marketing activities will also be discussed. 9-10 June Php6,000.00
Licensing Seminar on A.O. 34 for Drug Distributors (LSD-DD) This is a 1-day seminar intended for drug distributors (importers, exporters, wholesalers, and others as defined by AO 2014-034). Good Distribution and Storage Practice (GDSP) will be highlight of this seminar. Regulatory requirements and processes will be discussed along with related post-marketing activities attachedto the License-to-Operate (LTO) as Drug Distributors. 9 August

10 August
11 August
Php3,000.00
    CENTER FOR COSMETIC REGULATION AND RESEARCH​
13 ASEAN Modules & GMP for Cosmetic Manufacturers and Traders (13 ASEAN-GMP-CMT) A 2-day Licensing Requirement for Cosmetic and HHS Manufacturers and Traders. An introduction to ASEAN Cosmetic Harmonization 10-11 May

5-6 July

27-28 September

8-9 November
Php6,000.00
    CENTER FOR FOOD REGULATION AND RESEARCH
Good Manufacturing Practices (GMP) for Food Manufacturers and Traders (as per A.O. 153 s. 2004) A 1-day seminar on good manufacturing practices required for LTO of food establishments. 13 April

13 May

12 August

11 November
Php3,000.00

FDA Advisory No. 2016-031 - Postponement of FDA Academy Training Schedule for the Month of April and May 2016

FDA Academy

The FDA Academy is the Food and Drug Administration Philippines’ response to the challenge of providing educational platform for its employees, students, industries it regulate, and other stakeholders pursuant to RA 9711 or the FDA Act of 2009. With the tagline “Innovating Knowledge, Empowering People,” the FDA Academy is the key to educating the Filipinos on the role of regulatory enforcement in nation building.

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