This workshop provides a practical and comprehensive overview of the Scottish Medicines Consortium (SMC) submission process, led by Dr Catriona McMahon, Lead Industry Member for SMC.

Designed for pharmaceutical companies preparing submissions in 2026 and 2027, as well as consultancies supporting those submissions, the workshop offers practical guidance on the requirements, expectations and key stages of the SMC process.

Participants will gain a clearer understanding of what to consider when planning a submission and what to expect as submissions are assessed.  In addition, common challenges that may be encountered during the process will be discussed, as will approaches that can help strengthen the quality of submissions.

The programme covers the core SMC submission process in detail, including the different types of submission available, the unique-to-Scotland Ultra-Orphan Pathway, PACE and PAS revision, the Interim Acceptance option and the Fast Track Resubmission route.  The workshop will also cover how SMC makes their decisions.  

A guest speaker from the SMC will provide an update on current SMC activity and offer participants the opportunity to ask questions directly.

The workshop will cover:

• How to prepare effectively for submission to SMC.
• How to determine the most appropriate type of submission.
• What to expect throughout the submission process.
• Common challenges and considerations during assessment.
• Current SMC procedures and requirements.

To support discussion and interaction, places are limited to 16 participants per date, with a maximum of two places available per company.

Following the workshop, attendees will receive a copy of the presentation slides together with an FAQ document summarising all the questions that have been asked during previous workshops and the responses provided.

The workshop takes place online across two consecutive morning sessions:

• Session 1: Monday, 09:30–12:30
• Session 2: Tuesday, 09:30–12:30

The workshops are suitable for anyone involved in preparing, reviewing or supporting SMC submissions who would benefit from a detailed understanding of the process and current requirements.

Further information on available dates and fees can be found in the tabs at the top of the page.

For any additional questions, please contact the ABPI Events Team at events@abpi.org.uk