As a follow-up to the launch of the National PV Program, SIAPS conducted a three-day training session (September 2-4, 2013) on PV and regulatory systems for focal persons from each of the 20 selected public and private hospitals and DGDA officials. Training sessions were facilitated by SIAPS representatives from headquarters and Bangladesh; a consultant from Washington University, Dr. Andy Stergachis; senior officials from the DGDA; a professor from Dhaka University; the Expanded Program of Immunization program manager; line director, TB; and the head, Pharmacology Department, Dhaka Medical College and Hospital.
The objectives of the training were to:
- Give an overview on PV practices and support the Operationalization of guidelines and reporting forms for the ADRM Cell, ADRAC, DGDA, and other relevant stakeholders of the PV focal persons.
- Conduct regulatory system training for DGDA staff, committee members, and reviewers on key and emerging regulatory topics, including the quality management system, Good Regulatory Practices (GRP), quality assurance (QA), and Good Manufacturing Practices (GMP)
The topics also included:
- Good PV practices.
- Operationalizing the PV guidelines and the suspected adverse events reporting forms.
- Data quality management.
- Spontaneous reporting of ADR events and other sources of safety information
The PV focal persons are aware of the PV system being established in the country and have been oriented on the ADR reporting format. They also benefited by learning from one another about ADR related activities taking place in their hospitals. The DGDA officials had the opportunity to gain a better understanding of the common technical documents and their importance and use for ensuring GMP, GRP, and QA.