COURSE CALENDAR 2015 - Other Seminar

COURSE CALENDAR 2015
TITLE COURSE DESIGN DATE REMARKS
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.
Oct. 22-23 Course Fee
Php 4,000.00
Limited to 50
participants
per session
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
attached to the License-to-Operate (LTO) as Drugstore/Outlet.
April 28
April 29
June 24
June 25
Sept. 16
Sept. 17
Sept. 18
Course Fee
Php 3,000.00
Limited to 70
participants
per session
Licensing Seminar on A.O. 34 for
Drug Manufacturers (LSD-DM)
This is a 1-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.
June 17
June 18
June 19
Course Fee
Php 3,000.00
Limited to 70
participants per
session
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.
August 12
August 13
August 14
Course Fee
Php 3,000.00
Limited to 70
participants
per session
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
June 30-July 1
Sept. 15-16
Nov. 10-11
Course Fee
Php 6,000.00
Limited to 70
participants
per session
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.
June 30
Nov. 27
Course Fee
Php 3,000.00
Limited to 70
participants
per session
CENTRAL LABORATORY
Training on Quality Assurance
of Health Products
A 2-day training intended for laboratory personnel.
Principles of Good Laboratory Practices (GLP), Method
Validation, Laboratory Business Process and Laboratory
Accreditation will be highlights of this activity.
12-13 Nov. Course Fee
Php 6,000.00
Limited to 70
participants
per session

Courses Calendar 2015

COURSE CALENDAR 2015
QUALIFIED PERSON IN INDUSTRY REGULATORY AFFAIRS (QPIRA)
TRAINING ACCREDITATION as per FDA MC. No. 2013-004
TITLE COURSE DESIGN DATE REMARKS
QPIRA for Center for Food Regulation and Research (QCFRR)
• Licensing
• Registration
• Other related processes for Authorization
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.  March 12-13
April 23-24
May 21-22
July 9-10   
August 19-20
Sept. 24-25  
October 15-16    
Course Fee
Php 6,000.00                
Minimum of 50 and maximim
of 70 participants per session
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. April 16-17    
July 16-17
Nov. 12-13   
Course Fee
Php 6,000.00               
Minimum of 50 and maximim
of 70 participants per session   
QPIRA for Center for Cosmetic  Regulation and Research (QCCRR)
• Licensing
• Registration
• Other related processes for Authorization
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 CFRR and Post Marketing Surveillance, Releasing (ICTMD), Fees and Charges. March 9-10
May 19-20
August 4-5
October 6-7
Course Fee
Php 6,000.00
Minimum of 50 and maximim
of 70 participants per session   
QPIRA for Center for Cosmetic  Regulation and Research - Household Urban Hazardous Products (QCCRR-HUHS)
• Licensing
• Registration
• Other related processes for Authorization
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 CFRR and Post Marketing Surveillance, Releasing (ICTMD), Fees and Charges. June 10-11
September 8-9
November 4-5  
Course Fee
Php 6,000.00
Minimum of 50 and maximim of
70 participants per session
QPIRA for Center for Device Regulation, Radiation Health and Research (QCDRRHR)
• Licensing
• Registration
• Other related processes for Authorization
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 March 23-24
June 22-23
Sept. 21-22
Nov. 23-24
Course Fee
Php 6,000.00
Minimum of 50 and maximim of
70 participants per session
QUALIFIED PERSON IN INDUSTRY REGULATORY AFFAIRS (QPIRA)
& OTHER TRAINING PROGRAM for FIELD REGULATORY OPERATION OFFICE  (REGIONAL)
TITLE COURSE DESIGN DATE REMARKS
QPIRA for Center for Food Regulation and Research (QCFRR)
• Licensing
• Registration
• Other related processes for Authorization
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. July 30-31 (Baguio)
Sept. 3-4 ( General Santos City)
Oct. 1-2 (Bohol)
Course Fee
Php 6,000.00
Minimum of 50 and maximum of
70 participants per session
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. July 30-31 (Baguio)
Sept. 3-4 ( General Santos City)
Oct. 1-2 (Bohol)
Course Fee
Php 6,000.00
Minimum of 50 and maximum of
70 participants per session
QPIRA for Center for Cosmetic  Regulation and Research - Household Urban Hazardous Products (QCCRR-HUHS)
• Licensing
• Registration
• Other related processes for Authorization
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 CFRR and Post Marketing Surveillance, Releasing (ICTMD), Fees and Charges. July 30-31 (Baguio)      Sept. 3-4 ( General Santos City)
Oct. 1-2 (Bohol)
Course Fee
Php 6,000.00
Minimum of 50 and maximum of
70 participants per session
QPIRA for Center for Device Regulation, Radiation Health and Research (QCDRRHR)
• Licensing
• Registration
• Other related processes for Authorization
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 July  28-29
(Pampanga)
Course Fee
Php 6,000.00
Minimum of 50 and maximum of
70 participants per session

 

 

COURSE CALENDAR FIRST QUARTER 2015

COURSE CALENDAR FIRST QUARTER 2015   

QUALIFIED PERSON IN INDUSTRY REGULATORY AFFAIRS (QPIRA)

TITLE COURSE DESIGN DATE REMARKS
QPIRA for Center for Cosmetic  
Regulation and Research (Cosmetics)
A 2-day training-accreditation intended for company
liaison officer to become FDA accredited QPIRA for
Center for Cosmetic Regulation and Research. Aimed at
providing guidance on product notification requirements
to acquire Marketing Authorization
March 9-10, 2015 Course Fee
Php 6,000.00
Minimum of 50
and maximum of
70 participants
per session

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 guidance on acquiring market authorizations
such as License to Operate (LTO) and Certificate of
Product Registration (CPR) from CFRR
March 12-13, 2015 Course Fee   
Php 6,000.00
Minimum of 50
and maximum of
70 participants
per session

QPIRA for Center for Device,
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
March 23-24, 2015 Course Fee
Php 6,000.00
Minimum of 50
and maximum of
70 participants
per session
Training Courses for Center for Drug Regulation and Research (CDRR)
i.e. QPIRA, Licensing for Drug Distributors and Drugstores/Outlets
Establishments (as per A.O. 2014-0034 formerly A.O. 56)
  Schedule will be posted by
second week of March 2015
(Wait for further announcement)
 

FDA Academy Course Calendar 2014

CENTER FOR DRUG REGULATION AND RESEARCH (CDRR)

Title

Course Code

Course Design

Date

Status

Remarks

Pharmacovigilance Regulations and Guidelines for PV Officer  PV-RGPO  A 3-day course intended for PV Officers of Pharmaceutical Companies focusing on FDA Pharmacovigilance Guidelines, Rules and Regulations.  09-11 July OPEN

Course Fee Php 5,000.00

Limited to 50 participants per session

05-07 November OPEN
Licensing Seminar for Drug Outlets and Drug Establishments (as per AO 56)  LSD-OE-NI   11 April CLOSED

Course fee Php 3,000.00

Limited to 70 participants per session      

18 July CLOSED
17 October CLOSED
Licensing Seminar for Drug Manufacturers and Traders (as per AO 56)    LSD-MT        10 April  OPEN
17 July  OPEN 
16 October  OPEN 

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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