FDA Academy

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COURSE CALENDAR 2013 COURSE CALENDAR 2013 TITLE TITLE Pharmacovigilance Regulations and Guidelines for PV Officer COURSE DESIGN COURSE DESIGN A 3-day course intended for PV Officers of Pharmaceutical Companies focusing on FDA Pharmacovigilance Guidelines, Rules and Regulations. A 1-day course which discusses advance Pharmacovigilance in relation with good business practice, signal detection, risk management means to innovator and generics as well as the role of the QPPV. A 2-day course required for LTO of drug manufacturers and traders. DATE DATE 20-22 February 26-28 June 25-27 September 27-29 November REMARKS REMARKS Course Fee Php 5,000.00 Limited to 50 participants per session Course Fee Php 3,000.00 Limited to 50 participants per session Course fee Php 6,000.00 Limited to 70 participants per session Course Fee Php 3,000.00 Limited to 70 participants per session Course fee Php 3,000.00 Limited to 70 participants per session Course fee Php 6,000.00 Limited to 70 participants per session Course fee Php 6,000.00 Limited to 70 participants per session

Special Course on Pharmacovigilance

with International Renowned PV Resource Speaker:

26 March

DR. BRIAN EDWARDS Licensing Seminar on A.O. 56 for Drug Outlets and Drug Establishments (Manufacturers and Traders) Food Licensing and Regulation Seminar as per FDA Circular No. 2012-008

7-8 March 20-21 May 8-9 August 3-4 October

A 1-day seminar required for LTO 4 March of food establishments as per FDA Circular No. 2012-008. 7 June 4 September 6 November

Good Manufacturing Practices (GMP) as per AO 153 Series of 2004

A 1-day seminar on good manufacturing practices required for LTO of food establishments.

1 April 3 July 26 August 25 November 4-5 April 27-28 May 26-27 August 18-19 November 11-12 April 3-4 June 2-3 September 18-19 November

13 ASEAN Modules & GMP Modules for Cosmetic Manufacturer

A 2-day Licensing Requirement for Cosmetic and HHS Manufacturers. An introduction to ASEAN Cosmetic Harmonization. A 2-day course Licensing Requirement for Cosmetic and HHS Traders. An introduction to ASEAN Cosmetic Harmonization.

13 ASEAN Modules Compressed GMP for Cosmetic Traders

TITLE TITLE 13 ASEAN Modules GMP for Cosmetic Manufacturers (Toilet Soap)

COURSE DESIGN COURSE DESIGN A 2-day course designed for cosmetic manufacturers of toilet soap.

DATE DATE 08-09 July 21-22 October

REMARKS REMARKS Course Fee Php 6,000.00 Limited to 70 participants per session Course Fee Php 6,000.00 Limited to 60 participants per session Course fee Php 3,000.00 Limited to 50 participants per session Course Fee Php 9,000.00 Limited to 50 participants per session Course fee Php 9,000.00 Limited to 50 participants per session

Quality Assurance on Pharmaceuticals

Common Submission Dossier Template (CSDT) Training

A 2-day training to enhance the technical expertise of the pharmaceutical industry (manufacturers) analyst regarding good laboratory practices. A 1-day harmonized technical regulatory requirements for medical device industry in the ASEAN region. A 3-day course focusing on standards and regulation of the Department of Health for operating medical x-ray facilities intended for licensed radiologic technologist. A 3-day course intended for radiation safety officers, engineers of industrial x-ray facilities and anti-crime X-ray security officers to enhance knowledge about radiation safety and adherence to proper radiation protection practices with x-ray generating device/s. A 2-day course intended for dentists and dental personnel focusing on the compliance with the standards and regulation of DOH for operating dental x-ray facilities. A 3-day training course aimed at providing guidance to x-ray/radiologic technologist involved in the implementation of a Quality Assurance Program (QAP) in Medical Radiography.

19-20 September 23-24 September 10 April 16 August 16 October 6-8 May

Radiation Safety Course for Officers of Medical X-ray Facility

28-30 October

Radiation Safety Course for Officers of Industrial and AntiCrime X-ray Facilities

17-19 July

19-21 August Course fee Php 6,000.00 Limited to 50 participants per session Course fee Php 9,000.00 Limited to 50 participants per session

Radiation Safety Course for Officer of Dental X-ray Facilities

22-23 July 29-30 August 29-30 July 22-23 August

Technical Quality Control In Medical Radiography

FDA Academy
Q
Innovating KNOWLEDGE, Empowering PEOPLE

TITLE TITLE Radiation Safety for Officer using Radiofrequency Radiation Quality Control Test in Radiofrequency, Fluoroscopy and Darkroom Tests Radiation Protection for X-Ray Equipment Service Personnel

COURSE DESIGN COURSE DESIGN A 3-day training course aimed at providing radiation safety for personnel using radiofrequency radiation. A 3-day training course which discusses the quality control test in radiofrequency, fluoroscopy and darkroom tests Radiologic Technologist. A 3-day training course designed to equip the engineers and service personnel on the importance of radiation protection.

DATE DATE 22-24 May 24-26 July 17-19 April 9-10 May 24-26 April 23-25 October

REMARKS REMARKS Course Fee Php 9,000.00 Limited to 50 participants per session Course Fee Php 9,000.00 Limited to 50 participants per session Course fee Php 9,000.00 Limited to 50 participants per session

REGISTRATION PROCEDURE: 1. Proceed to the POLICY AND PLANNING OFFICE at Rm. AB-313 (3rd Floor Annex Building) to get the "Assessment and Registration Form (ARF)". OR Download the ARF on the FDA website at www.fda.gov.ph or beta.fda.gov.ph. NOTE: If the Seminar/Training needs submission of requirement/s, the applicant shall furnish the requirement/s completely. 2. Completely fill-out the ARF in triplicate copies. The assigned staff at PPO shall check the completeness of ARF and the needed requirement/s. When completeness is determined, the PPO assigned staff shall sign the ARF and secure the applicant's requirement/s. 3. Proceed to the Accounting Office at Rm. 113 (Ground Floor, Main Building) and present the ARF. The Assigned staff at the Accounting Office shall retrieve one copy of applicant's ARF and issue "Order of Payment Form (OPF)". 4. Bring the ARF together with the OPF to the cashier and pay the quoted registration fee. The cashier shall issue official receipt (OR) to the applicant upon payment. 5. Return one copy of ARF with printed OR number to the assigned staff at PPO. TERMS AND CONDITIONS: 1. Courses will start at exactly 08:00 AM and will finish at 05:00 PM, late comers will not be accepted and their registration fee shall be forfeited. 2. Registration fee is non-refundable and non-transferrable. 3. FDA reserves the right to cancel or re-schedule courses within three (3) days notice. In the event of such cancellation, participants shall be re-scheduled towards the next available course schedule.

FDA Academy
Innovating KNOWLEDGE, Empowering PEOPLE

QUALIFIED PERSON IN INDUSTRY REGULATORY AFFAIRS (QPIRA) QUALIFIED PERSON IN INDUSTRY REGULATORY AFFAIRS (QPIRA) TRAINING--ACCREDITATION as per FDA MC No.. 2013--004 TRAINING ACCREDITATION as per FDA MC No 2013 004 REQUIREMENTS: 1. 2. 3. 4. 5. Fully completed QPIRA Data Form (downloadable at www.fda.gov.ph or beta.fda.gov.ph). Two (2) pieces recent 2x2 colored photo with white background Certification from the company authorizing the person as the company liaison officer or regulatory affairs officer. Letter of no Objection from all companies (only for registrants representing more than one company). Php 6.000.00 affiliation fee for each additional company the QPIRA is authorized to represent. Company representation is based on the number of LTO. TITLE TITLE QPIRA for Center for Food Regulation and Research (CFRR) COURSE DESIGN COURSE DESIGN A 2-day training-accreditation intended for company liaison officer to become FDA accredited QPIRA for Center for Food Regulation and Research. A 2-day training-accreditation intended for company liaison officer to become FDA accredited QPIRA for Center for Drug Regulation and Research. A 2-day training-accreditation intended for company liaison officer to become FDA accredited QPIRA for Center for Cosmetic Regulation and Research. DATE DATE 14-15 March 13-14 May 1-2 July 9-10 September 16-17 May 20-21 June 5-6 September 4-5 November 11-12 March 5-6 August 10-11 October 7-8 November QPIRA for Center for Device, Radiation Health and Research (CDRHR) A 2-day training-accreditation intended for company liaison officer to become FDA accredited QPIRA for Center for Device Regulation, Radiation Health and Research. 4-5 April 11-12 July 16-17 September 11-12 November Course fee Php 6,000.00 Limited to 50 participants per session REMARKS REMARKS Course Fee Php 6,000.00 Limited to 50 participants per session Course Fee Php 6,000.00 Limited to 50 participants per session Course fee Php 6,000.00 Limited to 50 participants per session

QPIRA for Center for Drug Regulation and Research (CDRR)

QPIRA for Center for Cosmetic Regulation and Research (CCRR)

FDA Academy
Innovating KNOWLEDGE, Empowering PEOPLE for more information, please contact:

POLICY AND PLANNING OFFICE

Tel. +62 2 809 5045 local 8302 | Email: academy@fda.gov.ph Rm. AB-313, 3rd Floor Annex Building Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City, 1781 Philippines