Consultants Pharmacovigilance Systems Strengthening

Output 1.1: Conduct a detailed landscape and SWOT analysis of vigilance systems within the BoMRA and related stakeholders in Botswana.

Output 1.2: Review guidelines, Standard Operating Procedures (SOPs) working tools, and regulatory actions and decisions aligned with WHO Global benchmarking standards.

Output 1.3: Provide review of

- Evaluation of Risk Management Planning (RMP) and related documents

- Safety Communication and Vigilance data Publication

- Vigilance documents during conduct of Good Vigilance Inspections

- Implementation of IDPs at Adverse Drug Reaction Monitoring Centres (AMCs) against the Field Visit Manual for Assessing the Performance of Vigilance Function

Output 1.4: Provide guidance on communication to BoMRA stakeholders on

- Activities to be conducted to enhance understanding and compliance to regulations and guidelines

1. Deliverables:

· Monthly Progress Reports - Monthly written reports summarizing:

· Activities conducted Progress against IDP milestones

· Challenges encountered and mitigation actions

· Recommendations for the next period

· Comprehensive end of activity report on vigilance systems within the BoMRA and stakeholders, including activities conducted and recommendations on how to strengthen existing systems.

· GBT implementation status >95% completion by March 2027.

· Review of training materials, including presentations, handouts, and session summaries for safety surveillance and causality assessment.

· Recommendations for sustaining and accelerating progress