Consultancy & Advice.

• Assessment of individual case safety reports (ICSRs) and clusters of cases for both pre‑marketing clinical trials and post‑marketing reports.

• Evaluation of pre‑ and post‑marketing safety signals, including signal management when required.

• Advice on establishing Data Safety Monitoring Boards (DSMBs) and Safety Advisory Committees, as well as serving as chair or member.

• Support in setting up and participating in crisis‑management activities.

• Support for pharmacovigilance sections of regulatory submissions and responses, including major referrals.

• Strategic and operational advice throughout the regulatory process.

• Conducting one‑off or ongoing benefit–risk evaluations using conventional or formal B/R methods such as Multi‑Criteria Decision Analysis (MCDA).

• Strategic and operational advice on risk management, including proposing data reviews, synthesising evidence, and recommending studies only when necessary.

• Guidance on Risk Management Plans (RMPs).

• Advice on Additional Risk Minimisation Measures (aRMMs)—including whether they are needed, which measures are appropriate, and how to implement and monitor the effectiveness of additional risk minimisation measures.

Saad Shakir advises on, leads, or oversees the design and conduct of real‑world pharmacoepidemiological studies. Support includes:

• Deciding whether a study is necessary or if the question can be answered through alternative approaches (e.g. literature review).

• Selecting the appropriate study design (for example, cohort, case‑control, cross‑sectional, safety clinical trial or others).

• Defining the study population.

• Identifying the most suitable data source (e.g., electronic health records such as CPRD, Scandinavian data sources, or surveys).

• Recommending the right service provider.

• Advising on the most appropriate country or countries in which to conduct the study.

• Providing real‑world evidence for regulatory approval and beyond. Regulatory authorities increasingly require post‑authorisation studies to monitor long‑term safety, demonstrate effectiveness, and support risk minimisation.

• Supporting small and medium‑sized pharmaceutical and biotechnology companies that lack internal resources for RWE generation or evaluation. Support can be project‑based or ongoing.

• Assisting companies in conducting real‑world studies or registries required for early access to medicines.

• Advising on how to use RWE to support clinical development, regulatory approval, market access, and the long‑term safe use of products.

• Strategic and operational planning for RWE across the entire product lifecycle.

• Advice and support for establishing product or disease registries.