fda academy course calendar 2013

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Pharmacovigilance Regulations and Guidelines for PV Officer

A 3-day course intended for PV Officers of Pharmaceutical Companies focusing on FDA Pharmacovigilance Guidelines, Rules and Regulations.

20-22 February Course Fee Php 5,000.00 Limited to 50 participants per session

26-28 June

25-27 September

27-29 November

Special Course on Pharmacovigilance with International Renowned PV Resource Speaker:

DR. BRIAN EDWARDS

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.

26 March

Course Fee Php 3,000.00 Limited to 50 participants per session

Licensing Seminar on A.O. 56 for Drug Outlets and Drug Establishments (Manufacturers and Traders)

A 2-day course required for LTO of drug manufacturers and traders.

7-8 March Course fee Php 6,000.00 Limited to 70 participants per session

20-21 May

8-9 August

3-4 October

Food Licensing and Regulation Seminar as per FDA Circular No. 2012-008

A 1-day seminar required for LTO of food establishments as per FDA Circular No. 2012-008.

4 March Course Fee Php 3,000.00 Limited to 70 participants per session

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 Course fee Php 3,000.00 Limited to 70 participants per session

3 July

26 August

25 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.

4-5 April Course fee Php 6,000.00 Limited to 70 participants per session

27-28 May

26-27 August

18-19 November

13 ASEAN Modules Compressed GMP for Cosmetic Traders

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


3-4 June

2-3 September

18-19 November

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13 ASEAN Modules GMP for Cosmetic Manufacturers (Toilet Soap)

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

08-09 July Course Fee Php 6,000.00 Limited to 70 participants per session 21-22 October

Quality Assurance on Pharmaceuticals

A 2-day training to enhance the technical expertise of the pharmaceutical industry (manufacturers) analyst regarding good laboratory practices.

19-20 September Course Fee Php 6,000.00 Limited to 60 participants per session 23-24 September

Common Submission Dossier Template (CSDT) Training

A 1-day harmonized technical regulatory requirements for medical device industry in the ASEAN region.

10 April Course fee Php 3,000.00 Limited to 50 participants per session

16 August

16 October

Radiation Safety Course for Officers of Medical X-ray Facility

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.

6-8 May

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

28-30 October

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

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.

17-19 July

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

19-21 August

Radiation Safety Course for Officer of Dental X-ray Facilities

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.

22-23 July Course fee Php 6,000.00 Limited to 50 participants per session 29-30 August

Technical Quality Control In Medical Radiography

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.

29-30 July Course fee Php 9,000.00 Limited to 50 participants per session 22-23 August



Radiation Safety for Officer using Radiofrequency Radiation

A 3-day training course aimed at providing radiation safety for personnel using radiofrequency radiation.

22-24 May Course Fee Php 9,000.00 Limited to 50 participants per session

24-26 July

Quality Control Test in Radiofrequency, Fluoroscopy and Darkroom Tests

A 3-day training course which discusses the quality control test in radiofrequency, fluoroscopy and darkroom tests Radiologic Technologist.

17-19 April Course Fee Php 9,000.00 Limited to 50 participants per session

9-10 May

Radiation Protection for X-Ray Equipment Service Personnel

A 3-day training course designed to equip the engineers and service personnel on the importance of radiation protection.


23-25 October

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.


http://www.fda.gov.ph/

REQUIREMENTS:

1. Fully completed QPIRA Data Form (downloadable at www.fda.gov.ph or beta.fda.gov.ph). 2. Two (2) pieces recent 2x2 colored photo with white background 3. Certification from the company authorizing the person as the company liaison officer or regulatory affairs officer. 4. Letter of no Objection from all companies (only for registrants representing more than one company). 5. 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.


QPIRA for Center for Food Regulation and Research (CFRR)

A 2-day training-accreditation intended for company liaison officer to become FDA accredited QPIRA for Center for Food Regulation and Research.

14-15 March Course Fee Php 6,000.00 Limited to 50 participants per session

13-14 May

1-2 July

9-10 September

QPIRA for Center for Drug Regulation and Research (CDRR)

A 2-day training-accreditation intended for company liaison officer to become FDA accredited QPIRA for Center for Drug Regulation and Research.

16-17 May Course Fee Php 6,000.00 Limited to 50 participants per session

20-21 June

5-6 September

4-5 November

QPIRA for Center for Cosmetic Regulation and Research (CCRR)

A 2-day training-accreditation intended for company liaison officer to become FDA accredited QPIRA for Center for Cosmetic Regulation and Research.

11-12 March Course fee Php 6,000.00 Limited to 50 participants per session

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.


11-12 July

16-17 September

11-12 November


for more information, please contact:

POLICY AND PLANNING OFFICE

Tel. +62 2 809 5045 local 8302 | Email: [email protected] Rm. AB-313, 3rd Floor Annex Building

Civic Drive, Filinvest Corporate City, Alabang, Muntinlupa City, 1781 Philippines

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http://www.fda.gov.ph/

fda academy course calendar 2013

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