Working at the MHRA A day in the life of a Pharmaceutical Assessor. Seun Sogbesan, Associate Pharmaceutical Assessor 16 th April 2015
Presentation Aims To provide an insight into the day-to-day role of a pharmaceutical assessor To do some myth-busting To encourage you to consider working for the MHRA 2
The Agency s vision We protect and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research. 3
MHRA The Regulatory Body UK Regulatory Agency & Licensing Authority for medicines and medical devices Represents the UK on international bodies, which work to set consistent standards for medicines and medical devices world wide Involved in procedures for over 1000 new applications (both generics and new active substances) in 2014 4
To obtain a UK Marketing Authorisation The company prepares and submits a dossier (Common Technical Document) CTD describes the product from discovery through to commercialisation CTD consists of 5 modules module 1: Administration information module 2: Expert Overall Summaries module 3: Quality (Chemistry, Manufacturing and Controls) module 4: Toxicological/Preclinical module 5: Clinical dossiers are professionally assessed against QUALITY, SAFETY & EFFICACY increasingly, applications are being granted on a pan European basis [centralised procedure/decentralised procedure/mutual recognition procedure] 5
Pharmaceutical Assessors (PAs) Within Product Licensing, a large team of assessors work within the Clinical Trials unit, Biologicals unit, Parallel Imports unit and Product Life-cycle Assessment Teams Pharmaceutical/Quality assessors work as part of a multidisciplinary team alongside clinical, non-clinical and statistics and pharmacokinetics assessors (as required) Role: to assess the quality aspects of both initial and variation applications for marketing and take decisions on their suitability for approval 6
A day in the life Start by planning day s work around upcoming deadlines The rest of the day may be taken up with; assessing a new application for a product tablet, parenteral, inhaler, cream, patch assessing a proposed change to the licence presenting a challenging product/potential rejection to an Expert Committee e.g. CHM 7
A day in the life discussing an observation with colleagues in Inspectorate Providing scientific advice to an company Training sessions/cpd seminars Corresponding with applicants/european colleagues Flexibility and time management are key 8
Assessing the CMC section of an application A good oversight of Chemistry, Manufacturing and Controls (drug substance and product) is required. PAs also assess product information (SPC, PIL and labelling). Focus on breadth Credit for images: Shutterstock 9
Typical background of assessors (pharmaceutical) Pharmaceutical assessors are required to be EU registered pharmacists (exception for work in Biologicals) Typically an assessor might hold a PhD or have a good level of relevant experience e.g. manufacturing, R&D (chemical or pharmaceutical development), quality control, regulatory affairs Some assessors have a background in practice within hospital or community pharmacy 10
My career path up to now 11
The best thing about being an assessor 12
Key skills required Passion for science and quality medicines Attention to detail Analytical thinking Strong written and verbal communication skills Willingness to learn Ability to manage work and work flexibly to meet deadlines 13
Applying for pharmaceutical assessor roles Sign up to receive alerts for MHRA jobs, join the MHRA LinkedIn page Jobs are often advertised in the Pharmaceutical Journal, TOPRA website and LinkedIn Read more about the work of the Agency on the website e.g. work with ebola, e-cigarettes https://www.gov.uk/government/organisations/medi cines-and-healthcare-products-regulatory-agency Read up on drug regulation in the EU and the legal basis, dossier content, guidelines such as ICH Public assessment reports are published online 14
APS Regulatory Focus Group Available to APS members at no extra cost Can sign up online: My account -> Join focus group Real opportunity to contribute and shape this group COMING UP Regulatory Essentials: aimed at scientists fairly early in careers (Autumn 2015) For more information and to suggest topics; malcolm.dash@mhra.gsi.gov.uk or via APS 15
Additional Slides 16
MHRA - Overview Organisational structure 17