Understanding Pharmacoepidemiological Real-World studies and Real-World Evidence for Pharmaceutical Medicine

Wednesday 15 October 2025
09:30 - 17:00 (UK time)

Evidence generated from observational studies using real world data (RWD), outside of clinical trials, known as real world evidence (RWE), is increasingly being used to inform decision-making regarding the use of medicines. The use of RWE has gone beyond its usual domains of pharmacovigilance, pharmacoeconomic and outcomes research.

Real world (RW) studies are now conducted during the whole lifecycle of medicines, to  enhance drug discovery and development, as well as their contribution to studying post-authorisation safety and effectiveness. The potential for the use of RWE throughout the entire lifecycle of medicines will continue to grow.

All pharmaceutical physicians need to understand the principles, methods and applications of observational RW studies.

This one-day hybrid course aims to provide an introduction to RWE studies in the context of pharmaceutical medicine.

What will we cover?

  • Basic principles and value of real-world data in pharmaceutical medicine and research
  • Considerations in design of Observational Real World studies
  • Best practice guidelines for design of Real World Data studies
  • Real-World Evidence in action: shaping health care decisions
  • The future of Real World Evidence

This educational course will end with concluding remarks from Professor Saad Shakir. Delegates will be able to ask any questions and bring forward topics for discussion which had not been addressed earlier in the course.


Who should attend?

This full-day course will be introductory; no pre-requisites are required. It is suitable for pharmaceutical physicians and others working in the field of pharmaceutical medicine.


Speakers

Professor Saad Shakir MB ChB LRCP&S FRCP FFPM FISPE FISoP MRCGP Independent Consultant – Pharmacovigilance and Pharmacoepidemiology

Professor Deborah Layton FRPharmS FISPE, Drug Safety Lead, Lane Clark & Peacock LLP

Dr Ben Bray MBChB MD MPH MRCP MFPH FFCI, Partner and Evidence Generation Lead, Lane Clark & Peacock LLP


Where is this workshop taking place?

This one-day course is hybrid, so you have the option of either attending in person or attending online via Zoom.

The course will be delivered at the Royal College of Paediatrics and Child Health (RCPCH). You can find them here:

5-11
Theobalds Rd
London
WC1X 8SH

Morning refreshments and lunch will be provided to those attending in person. A member of the training team will be in touch with you to confirm any dietary or accessibility requirements.

If you select the online option, you will be contacted by a member of the training team who will provide you with Zoom joining information. You will also be provided the opportunity to ‘buddy up’ with an in person delegate to support engagement during the session.

Queries: If you are unable to complete your booking online, wish to book on behalf of someone else, or have any questions, please email training@fpm.org.uk.

Please see our Terms and Conditions and Privacy Policy.

Details

This course is hybrid, so you can either attend in person or online via Zoom. It will take place on:

Wednesday 15 October 2025, 09:00-17:30 (UK time)


Price options:

In person FPM member fee £175
In person non-member fee £225
In person PMST trainee fee £125

Online FPM member fee £125
Online non member fee £150
Online PMST trainee fee £100

If you select the online option, you will be contacted by a member of the training team who will provide you with Zoom joining information.

Reduced rates are available for FPM members who fulfil one of the following criteria: People from low and lower-middle income countries, Unemployed, part-time employed (earning less than £15,000 per year), People on Parental Leave, Junior Doctors, People on Parental Leave, Junior Doctors. Contact training@fpm.org.uk to find out more.
Booking closes on Wednesday 8 October at 12pm.
Please see our booking terms and conditions and our privacy policy

CPD Credits

You can find instructions and guidance regarding CPD eligibility here.

Approve for CPD

 

Agenda

TimeSession Title
09:30 Welcome (FPM & speakers) (Saad Shakir)
09:45 Basic principles and value of RWD (Saad Shakir)
  • Concepts of RWS and RWR and how these concepts differ to that of clinical trials
  • Sources of RWD (strengths and weaknesses)
  • Critical components of a typical observational RW study
  • Introduction to strengths and challenges of RWE (bias, confounding, missing data, misclassification)
  • Applications of RW studies: examples include early access to medicines, Post authorisation safety studies (PASS), effectiveness of risk minimisation activities, drug utilisation
  • Value of RWE research in pharmaceutical medicine
11:15 Refreshment break
11:30 Considerations in design of Observational RW studies (Deborah Layton)
  • Common study designs and statistical methods used in RWE
  • Common challenges in interpretation of study results
13:00 Lunch
14:00 Best practice guidelines for design of RWD studies (Deborah Layton)
  • Target trial emulation
  • Protocol development and assessment
  • Finding Fit for purpose data
15:00 Refreshment break
15:15 Real-World Evidence in Action: Shaping Health Care Decisions (Ben Bray)
  • RWE in regulatory, payer and health care implementation decision making
  • RWE in sequential decision making – preparing for the future
  • RWE in expedited authorisations
16:00 The future of RWE (Ben Bray)
  • Advances in the generation of RWE, including the use of artificial intelligence and machine learning
16:45 Closing Remarks (Saad Shakir)

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The views, information, or opinions expressed during FPM events and training are those of the individuals involved and do not necessarily represent those of the Faculty of Pharmaceutical Medicine. We value inclusivity, equality and diversity, and work hard to promote these whenever possible in all of our activities. We welcome your comments and feedback: events@fpm.org.uk