MHRA medical assessors tackle challenging evolving drug complexity

Medical assessors play a role in medicines licensing and post-marketing surveillance, helping ensure drugs are as safe as possible and deliver their intended benefits.

Last week, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) launched a campaign to highlight what medical assessors do in an attempt to try to attract people with a medical background considering a career move.

In-Pharmatechnologist.com spoke with Siu Ping Lam, Director of Licensing Division at the MHRA to find out more about what an assessor does, the evolving nature of the role, and what exactly the Agency is looking for:

First off, how many medical assessors does the MHRA currently employ?​

There are approximately 45 medical assessors who work across all therapeutic areas .

Our licensing division has a diverse range of responsibilities, including assessing and approving applications for marketing authorisations and granting clinical trial authorisations.

The Vigilance and Risk Management of Medicines (VRMM) division conducts post-marketing surveillance, operates the Yellow Card and other systems for reporting, investigating and monitoring adverse reactions to medicines.

What is the purpose of this campaign? ​

Our current campaign is not merely about recruiting but also raising the very important profiles of medical assessors and the important work that they contribute to the protection of public health.

We employ medically qualified assessors with different backgrounds and experiences, to ensure that we have sufficient expertise to carry out our duties. We advertise for new assessors as and when we need to fill gaps in our assessment teams. 

How do they work with pharma firms?​

Assessors interact with the pharmaceutical industry in a number of ways including the provision of scientific advice in face to face meetings, in clarification discussions with applicants during the assessment of a marketing authorisation application and in ad hoc meetings such as conferences and workshops.

And how do you ensure there is no conflict of interest?​

Assessors have to follow a strict COI policy that requires an annual declaration.  This is a requirement of the MHRA and of the EMA.  This includes work restrictions based on previous work experience with industry and financial interests in pharmaceutical companies. 

How about working with other regulatory bodies?​

Assessors are members and observers of numerous different committees and working parties at the EMA, contributing to the writing of guidelines and the medicines decision making process e.g. as Rapporteur clinical assessor in the centralised marketing authorisation procedure. Assessors also interact with the FDA for product specific and regulatory science issues.

How has the role changed over the past few years?​

The volume of work is increasing and becoming more complex and diverse. For example the agency is seeing more drug device combinations products and advanced therapies medicinal products.

What challenges has this led to?​

Frequent challenges include determining standard of care in crowded therapeutic areas and benefit risk conclusions, making decisions with more uncertainty, particularly with smaller datasets in personalised medicines and determining the regulatory acceptability of the increasing use of modelling and simulation to support marketing authorisation applications.

There is also the increase in biological therapies with their unique efficacy and safety profiles. This has then raised the challenges of regulating biosimilars. Increasingly the role of the medical assessor has broadened with increased dialogue with industry in order to facilitate the development of medicines for unmet medical needs.

Who is the MHRA looking for?​

Candidates need to demonstrate extensive expertise in their clinical practice/ specialist area. Assessors should enjoy the challenge of assimilating complex information and reaching robust evidence based decisions. Thus the ability to write clear and concise expert assessment reports is essential, as are good communication skills.

What would a typical day be for an assessor?​

There is no typical day, the work is very varied. Every day there will be a question to which you need to research the answer to. This provides personal development and challenge. Working for the agency provides its assessors with a wide range of CPD opportunities and career long learning. Assessors do not struggle in meeting the terms of Good Medical Practice required for revalidation. In addition it is a pleasure and informative to work with leaders in the field.