CENTER FOR DRUG REGULATION AND RESEARCH
Training and Advocacy for Hospitals:
Post Marketing Surveillance and Pharmacovigilance
PROGRAMME
Tagaytay City
18 September 2024
FACILITATOR/ASSIGNED
TIME ACTIVITY/TOPIC
PERSONNEL
8:00-9:00 AM Registration
Invocation FDA Team
9:00-9:05 AM
National Anthem
9:05-9:15 AM Welcome Remarks Ms. Maria Cecilia C. Matienzo
Director IV, CDRR, FDA
Program Overview
Ms. Janissa Therese G. Gutierrez
9:15-9:25 Expectation Setting
Master of Ceremonies
House Rules
9:25-9:30 AM Photo Opportunity FDA Team
Introduction to Post Ms. Jade Mae D. Biyo
9:30-10:00 AM FDRO, Post Marketing Surveillance (PMS)
Marketing Surveillance Section, PRSDD, CDRR, FDA
10:00-10:10 AM AM SNACK
Introduction of Substandard Ms. Jade Mae D. Biyo
10:10-10:40 AM
and Counterfeit Medicines FDRO, PMS Section, PRSDD, CDRR, FDA
10:40-11:10 AM Reporting of Substandard and Ms. Jade Mae D. Biyo
Counterfeit Medicines FDRO, PMS Section, PRSDD, CDRR, FDA
11:10-11:40 AM Compassionate Special Permit TBD
11:40-12:15 PM Open Forum
12:15-1:00 PM LUNCH
Introduction to
1:00-2:00 PM Mr. Mark Ryann A. Lirasan
Pharmacovigilance
FDRO, Pharmacovigilance (PV) Section,
Clinical Diagnosis of Adverse PRSDD, CDRR
2:00-2:45 PM
Drug Reaction
2:45-3:00 PM PM SNACK
How to Report Adverse Drug Mr. Mark Ryann A. Lirasan
3:00-4:00 PM
Reaction FDRO, PV Section, PRSDD, CDRR
4:00-4:30 PM Open Forum
4:30-4:50 PM Awarding of Certificates FDA Team
Ms. Maria Luisa L. De Sagun
4:50-5:00 PM Closing Remarks FDRO, RFO IVA Regional Supervisor
Field Regulatory Operations Office, FDA
Ms. Janissa Therese G. Gutierrez
Master of Ceremonies