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