Please note that applicants to this short course should go via King's Apply (click blue 'Apply' button above) and select the following programme*:

Pharmaceutical Medicine Non-Award (Part-time): Module Code 7MCS0016

Course content

• Advanced training in the principles of PV, PEp and PEc that are utilised across the product lifecyle.
• Provides an in depth understanding of the practical issues associated with PV and PEp studies according to current regulatory guidelines.
• Instills an in-depth understanding of risk management planning, evaluation of risks and risk mitigation during clinical trials, analysis and reporting of adverse event data, and critical appraisal of PV and PEp study designs.
• Enables students to develop a clear, articulate, and unbiased approach to the interpretation and assessment of data generated during drug development and from real world evidence.
• Enables students to develop methods to effectively disseminate information through both verbal presentations and the generation of written reports.

Learning outcomes

By the end of this module students will be able to:

• Analyse and report adverse event data from clinical trials and from real-world evidence.
• Critically appraise plans for clinical safety signal detection from spontaneous adverse event data and determine whether there is enough information to inform clinical decisions in practice.
• Use a range of national and international standards and regulations to design effective safety data collection and reporting strategies (Good PV and PEp Practice).
• Review the strengths and weaknesses of different methodologies used to generate PEp evidence.
• Employ PV and PEp skills, including statistical methodologies, to strategically evaluate a drug product and produce a risk management plan.
• Evaluate the impact of PEc on the health technology assessments and payor decision making.

Minimum entry requirements are either a medical degree (such as an MBBS) or a 2:1 first degree in pharmacy, pharmacology, biology, biochemistry, chemistry or related subject. The course will suit individuals seeking to develop a practical understanding of drug safety and pharmacoepidemiology e.g. pharmaceutical physicians, scientists in R&D and medical affairs, and regulatory affairs personnel.