Maximise Medical Affairs Value Creation, CED and Medical Affairs accreditation

A recent conversation with a student on how he is using ChatGPT to write his thesis made me reflect that the whole is greater than the sum of its parts, that education is only a part of what we bring to our professional lives, and that it’s important to remember that. It also made me think about the value of education, the importance of continuing education, and of something a tutor once said to a family member regarding the correlation between good university grades and career success. So, today’s blog talks about continuing education and how to select a course that suits your needs, why a good education is not enough to ensure career success and what you can do to increase your chances, and lastly I issue an invitation to present your work a the EU DIA medical information and communication meeting in September.

Topics for today’s blog are:

– Maximising Medical Affairs value creation
– Continuing education – or do you need to be board certified in Medical Affairs?
– Invest in yourself – or why a good education is not enough and what to do about it
– Call for abstracts DIA Medical Information Conference September 2023

Maximising Medical Affairs Value Creation

Since I joined the industry the role of Medical Affairs has come of age. Historically perceived to be a support function for commercial, Medical Affairs teams are now recognised to be critical partners for all aspects of a product’s lifecycle. Unfortunately, as companies evolve, the number of potential stakeholders keeps increasing and this, combined with the fact that workloads are also increasing, means it’s important to review your stakeholder engagement regularly and to have a game plan. In 2016 I surveyed Medical Affairs professionals on how they engage with other teams in their organisation and whether these meetings are structured or ad hoc. Most respondents said yes they do engage with other teams, but that these meetings are, for the most part, ad hoc based on need. Unfortunately, however, often opportunities are identified serendipitously, and this is most likely to happen if you have regular conversations on topics of common interest.

In order to demonstrate value to and benefit from the knowledge of other stakeholder groups in your organisation I’d suggest listing your key stakeholders and reviewing how you engage with them. If you have never worked with a certain group, consider setting up a meeting. And for key stakeholders it’s worth having cross-functional regular meetings set up. Most large organisations do this as a matter of course. I have listed some typical stakeholder groups below, as a starting point. You could review the stakeholders listed below, add in any that are missing from your perspective, then identify who it makes sense to engage with, who in your team is best placed to have the conversation, and then set up a short meeting to introduce yourself and take it from there.

Internal Stakeholders:

  • Marketing
  • Sales
  • Strategy Teams
  • Market Access
  • Regulatory Affairs
  • Quality
  • Compliance
  • PV
  • Digital Communication both Corporate and Medical
  • Clinical Development
  • R&D
  • Finance
  • Human Resources

External Stakeholders

  • Payers
  • HCPs
  • KOLs
  • Customers
  • Regulatory authorities
  • MOH/Governments
  • NGOs
  • Charities
  • Patient associations
  • External advocates – social leaders

Key takeaways for communicating value and for efficient collaboration: Regular exchange with key stakeholders within and outside your organisation can help you identify opportunities you risk missing if you only have ad hoc meetings.

Continuing Education – or do you need to be Board Certified in Medical Affairs?

Continuing education is important. However, time is limited, and there are more and more offerings targeted at Medical Affairs professionals. While continuing education is critical, picking the right course for your needs is paramount. I recommend a rigorous comparison of the available courses, the course curricula and the faculty. I have added a checklist below. In addition, I suggest you interview past participants, to find out whether the courses added value, as well as experts in your fields of interest. These conversations will help you identify what training will help you “break into” the fields of your choice especially if you are new to the industry or looking to change jobs within the industry.

Depending on your background and interests there are many courses you can take. Many specialist courses are available for free online. Free courses I have taken include bioethics, personalised medicine, computer programming as well as programme management and data analytics and visualisation. These courses are available from renowned universities taught by university lecturers and without exception they have been of exceptional quality.

For a university affiliated very comprehensive overview of Pharmaceutical Medicine, I’d recommend looking at the European Centre of Pharmaceutical Medicine (ECPM) Diploma Course. The course is targeted to individuals, who already have experience in the industry, it takes a year, comprises 6 modules and concludes with an assortment of exams. As a past Programme Director of the course I know it very well. The curriculum is broad and covers drug development and the business environment, non-clinical to first in human, clinical studies, safety data evaluation and biostatistics, global registration and approval processes as well as product development, the healthcare marketplace and marketing. The course is taught by global industry experts from the leading pharmaceutical companies and the modules are supplemented with extra courses on topics that are in focus in the industry. An added bonus is that as the ECPM is university affiliated you graduate with a university degree: a Certificate or Diploma of Advanced Studies in Pharmaceutical Medicine up to a Master of Advanced Studies in Medicines Development.

For courses focused on specialist areas such as Regulatory Affairs, Medical Information, Compliance etc. the Drug Information Association, CEL for pharma, the Medical Affairs society and others provide many courses of different duration and intensity, both on and offline, as do individual solution providers. In addition, some regulatory authorities also offer teaching materials, for example the FDA website provides videos and training material on compliance topics. There is a lot of information available if you know where to look.

This brings me to the Board Certification in Medical Affairs. The course covers many topics in 40 hours, it appears to be fast-paced, self-taught and all online, and US focused, which is apparent from the accreditation, based on what I could glean from the website. The final test is also online. According to a friend who recently took the course and who has many years of experience in the industry it would provide most value for those who are new to the industry, but is less likely to provide much value add if you already have significant industry experience. So do you need to be board certified in Medical Affairs to be successful? I would say definitely not, especially not ex-US, however for newcomers to the industry it might prove useful as a starting point.

Some things to consider when identifying the right course for you:

  • Are you a newcomer to the industry or an industry professional?
  • Are you clear on your goals for taking the course – what will change if you take it?
  • If you are new to the industry do you know enough to commit to a full course in a single area?
    • If you do not, consider speaking to an expert in the industry first to identify where your interests and talents might fit best
  • What are your long-term career goals?
  • What courses are available to you through your university, free resources your employer?
  • What is your learning style, on-line offline or a mix?
  • Is the course interactive, do you have access to teachers, other students etc.
  • Are you looking to change jobs or break into a new area?
  • For the courses you review – look at the faculty and compare their credentials, are they industry experts or university lecturers, or both. Ask to experience a couple of lectures or review some of the materials to get a feel for the quality of a course
  • Ask how often materials are updated, how they are reviewed and approved and kept current
  • Decide whether you need a university accredited degree or whether another certificate is enough
  • Review course duration, cost, relative cost and renewal costs

If you are looking to change jobs or enter into the industry, taking courses where you engage with others, ideally face to face, and engage with a senior teaching faculty, will help you learn more about the industry and give you access to experts in the field, which will be helpful when planning your future.

Key learning: There are many courses available, many are free, and I’d recommend the same care you’d use when picking a course as when buying a horse. Look it over carefully and be wary of marketing “blurb”.

Invest in Yourself – or why a good Education is not Enough and what to do about it

A family member went to Oxford University in the UK. His tutor said to him and his peers “many of you have brilliant grades, but I have met many students over the years, and I have noticed that success cannot be predicted by grades. In fact, I have seen many students who were academically unexceptional excel in their later careers”. We are taught to invest in our education and continued education. However, success cannot be predicted by good university degrees alone. Being interested, curious and educated are naturally important foundations for a career, however, that is all they are, a foundation. Having great connections also helps. However, what is most important is our ability to engage with others. If you are able to communicate efficiently, collaborate effectively and to gracefully navigate what a friend calls “corporate shenanigans” you are likely to go far.

How you interact, engage and collaborate with others is, I’d argue, more critical for career success than your university grades. What you have to say is important, but if you have ever watched a speaker and been distracted by his hand-movements, head movements or delivery, you will realise that what we think of others is based both on verbal and non-verbal communication. In fact, most communication is non-verbal. Consequently, a great education is important, continuing education is also critical, but they are not enough.

An aunt used to tell me “your best tools are your hands”. I would say “you are your best tool”. The more time you invest in understanding yourself and in being aware of the conditions that need to be met for you to be most effective, the happier you will be in your professional and personal life. Often individuals perceive obstacles in their paths that they have unwittingly generated themselves but that they feel powerless to remove. The good news is that as long as we are alive things can be changed, obstacles removed, perceptions changed, filters discarded, it may take time and effort, but the outcome is worth it. If you’d like an informal conversation to see if coaching might be something that can help you take that next great leap towards happiness, I’d be happy to speak to you.

Key Take-Away: You are your best tool, the better you understand yourself, the further you are likely to go in a direction that is congruent with who you are. This is an important key to happiness.

Call for Abstracts DIA Medical Information Conference September 2023

The Call for Abstracts for the Medical Information and Communications meeting is now open! This is a great opportunity for you to present your work to a diverse group of professionals and share your experiences with them.

Possible topics:

  • Customer Initiatives
  • Partnership with Stakeholders
  • Evolving the Med Info Structure
  • The Value of Med Info
  • AI Progression within Med Info
  • Compliance and Regulations
  • Other

Submit your abstract by April 19 and join the programme committee’s “open hours” to help you better prepare for your abstract submission. I will be hosting an open hour to discuss abstract submissions on 30th March at 10-11am CET together with co-hosts Marie-Luise Helmich, Sanofi and Michelle Bridenbaker, Idorsia.

Hope to see you there. If you have a topic that is not in the list but that you would like to present, why not dial in and share it with us?

Hope to see you there!

I hope my blog provides you with some useful insights and, as ever, I look forward to hearing your thoughts. And if you have a challenging project or would like to discuss coaching to help you achieve that next level, please reach out for an informal chat.

Best wishes

Isabelle C. Widmer

The whole is greater than the sum of its parts
Attributed to Aristotle
Photo by Isabelle Widmer, Nice