The meeting was held on 17 and 18 October 2019 in Athens, Greece, as a follow-up to the meeting held at Semmelweis University, Budapest, Hungary, in November 2018. This meeting served to further consolidate the networking and exchange of information of National Member Organisations (NMAs) in Europe. Invitees were NMA Presidents or Delegates.

Objectives of the meeting were:
• Revitalize the role of IFAPP in fostering Pharmaceutical Medicine as a scientific discipline and profession in Europe
• Increase awareness on the value of education, certification, accreditation, and competencies: IFAPP Academy and various academic course providers
• Align initiatives to achieving centralized professional certification
• Reconnect with European NMAs
• Celebrate the creation of new NMAs
• Create a European Working Group aimed at advancing critical objectives
• Foster internal and external collaborations.

Several posters were presented by the National Members Associations (NMAs) during the meeting. For more information, please click under News.

Three Workshops were held during the meeting:

• Ethics Group
• Patient Centricity
• Education

 

Breakout Session on Ethics

Participants:

Varvara Baroutsou, Greece; Johanna Schenk, Germany; Kotone (Koto) Matsuyama, Japan; Sandor Kerpel-Fronius, Hungary

The following three topical issues were discussed:

1. Digital medicine - The impact of the Implementation of the EU GDPR regulation on patients and public research. The national implementation raises many practical questions related to electronic case report forms, informed consent forms, patient reported outcomes, virtual clinical trials, etc. It was agreed to collect and discuss practical problems encountered by the National Member Associations (NMAs) of IFAPP in Europe. It is hoped that the exchange of experience might support the daily work of IFAPP members locally. This topic is in harmony with the project of the Working Group (WG) on Ethics suggesting that data sharing should be included into the planned revision of the Declaration of Helsinki.
2. Development of advanced therapy product in rare diseases. The aim is to guarantee further treatment with effective orphan drugs for trial participants after finishing a trial. This is a major challenge needing the cooperation of sponsors, investigators, regulatory agencies, patient organizations and also health technology assessment bodies. A recommendation for a complex approach to provide orphan drugs also for additional patients after conditional marketing approval at an acceptable price is already discussed in the WG on Ethics. The planned approach should also result in an improved collection of further data for final approval.
3. Free supply of expensive reference drugs for clinical trials aiming to prove biosimilarity. High price of the reference product increases development costs of biosimilars making the biosimilar drugs more expensive.

The attached poster which summarizes our discussion was prepared and excellently presented by Varvara.

The meeting participants accepted the presentation and encouraged the WG on Ethics to target several publications for dissemination and awareness-building on ethical issues relevant to pharmaceutical medicine.

Finally, it is my great pleasure to announce that three new colleagues joined the WG on Ethics during the meeting in Athens: Varvara Baroutsou, Kotone Matsuyama and Shehla Naseem from Pakistan.

The report was written by Sandor Kerpel-Fronius.

Patient Centricity Workshop

Participants:

Kyoko Imamura (Japan), Brigitte Franke-Bray (Switzerland), Marco Romano (Italy), Anna Rodet (France), Peter Stonier (UK), Anna Jurczynska (Spain).

The group exposed their view on how and where patients are currently engaged:

• Clinical study design: patients are invited to review and discuss study designs and Health Authorities follow their recommendations
• Medicine/Device usability: patients are asked to test some devices and their opinion is taken into consideration before the device is marketed
• Patient-Reported Outcomes: referred especially to Quality of Life
• Market Access: patients are invited by Drug Regulatory Agencies (DRAs), Health Technology Assessment (HTA), Advisory Boards
• Ethics Committee (EC): patients’ opinion is taken into consideration during protocols review by EC
• Children as experts in Clinical Research: children are trained to understand and disseminate information on clinical research, e.g. KIDS Madrid
• Pharmaceutical Medicine Curricula (KSA)
• Informed patients are of great value for Treatment Decisions or Medicine Adherence
• Professional/Expert Patients

What can IFAPP do?

• Sessions on Patient-Centered Medicine Development (ICPM 2020 in Rome)
• NMAs should be encouraged to create Working Groups on Patient Centricity. Such a WG could also be created in IFAPP.
• Share best practices via NMAs.
• Liaison with International Patient Associations, such as EUPATI, EURORDIS, ORPHANET

 

Education Workshop

During the last IFAPP European meeting in Athens a workshop to discuss the national educational needs in Pharmaceutical Medicine was held with National Member Association representatives.

This has been an initiative from the IFAPP Communication Working Group and it was coordinated by Gustavo Kesselring (IFAPP External Affairs) and Honorio Silva (IFAPP Past President).

NMAs representatives were Domenico Criscuolo (Italy) , Kwinten Bosman (The Netherlands) , Michael Huebschen (Germany) , Jiri Paseka (Czech Republic) and Anthony Chan (Ireland).

During one hour all NMAs representatives discussed what was their main need to improve education in Pharmaceutical Medicine in their countries and how IFAPP could help them in this regard.

The main conclusions and action points were as follows:

Netherlands: the development of a local matrix focused in Medical Affairs capabilities aligned with international standards and having IFAPP as benchmark.

Action: IFAPP will be invited to present its Core Competencies during the next Dutch National Association Conference.

Germany: convince the company leaders to support individual education for career progression

Action: IFAPP/IFAPP Academy to send a selling set presentation of IFAPP-King´s College Course.

Czech: same as Germany

Italy : Domenico Criscuolo informed that after a Law passed in 2008 making it mandatory all CROs employees responsible for clinical trials activities having a masters degree transformed the education Market in clinical research. Now Italy has 13 Master Courses in Clinical Research.

Action: keep advertising IFAPP-King´s College Course among Italian membership.

Ireland: Development of Modular short courses to fill CME national requirements

Action: IFAPP Academy has this activity in its plan for 2020-21.

 

TESTIMONIAL BY MARCIA PHILBIN, CHIEF EXECUTIVE, FPM

I recently had the pleasure of attending the IFAPP Academy’s Extended Board Meeting which took place on 15-17 October 2-19 in Athens, Greece.

It was an international meeting with colleagues from Europe, North America, South America and Asia. Notable delegates included three of the founders of the IFAPP Academy - FPM’s very own Peter Stonier, Professor Honorio Silva from the USA/Venezuela, and Gustavo Kesselring from Brazil. All attendees were very welcoming and by the end of the first day I felt right at home!

During the meeting I was particularly interested in hearing more about the IFAPP Academy’s flagship programme - Professional Certification Program in Medical Affairs in Medicines Development.  This is delivered in partnership with King’s College London to an international audience via an online e-classroom, and the IFAPP Academy has a specialised team who develop and manage this platform. It takes a year to complete the programme and successful candidates receive a certification. The completion rate is high and there is an online community of students that support as well as encourage one another. The most impressive thing that I learnt about the programme is the international nature of the candidates – 54 countries are represented!

I also attended the follow-up meeting of the IFAPP Europe Regional Meeting on 17-18 October 2019. Professor Peter Stonier’s presentation on FPM provided an overview of the history of the Faculty and how pharmaceutical medicine achieved its specialty training recognition for doctors in the UK. Judging by the plethora of questions, our international colleagues hold our Pharmaceutical Medicine Specialty Training (PMST) programme in extremely high regard and they were very keen to understand further the governance and processes which have gone into its development.

A further, important update from IFAPP is the Global Fellow Award. Our current President, Professor Tim Higenbottam, our Past President, Professor Alan Boyd as well as Professor Peter Stonier were part of the working group that developed the Global Fellow Award. We'll be sure to circulate the criteria for prospective applicants once they are available. IFAPP hope to hold the Global Fellow Award ceremony at the 20th International Conference on Pharmaceutical Medicine in Rome in March 2020 where our President, Professor Tim Higenbottam is a guest speaker.

Overall, my visit was informative and a great opportunity to meet international colleagues who are dedicated to promoting pharmaceutical medicine as a profession.

Kind Regards,

Dr Marcia Philbin, Chief Executive

Faculty of Pharmaceutical Medicine