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Conversations with the Academy series engenders considerable interest with learning community

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Conversations with the Academy

Under the umbrella of the IFAPP Academy’s Value Added Programs and Services, offering continuing professional development initiatives and avenues for networking for our expanding learning community, the Conversations with the Academy webinar programs have garnered enthusiastic engagement.

In the third event in the series Dr. Mark Lightowler, CEO, Phorix Limited, highlighted The Role of Digital Tools in Changing Health Behavior, exploring the evidence for behavioral change parameters – e.g., physical activity, medication adherence, smoking cessation — to be considered in health outcome programs, in tandem with patient engagement tools. While evaluating how innovative digital tools are unlocking our understanding of behavior and our ability to change, Dr. Lightowler shared insights and resources to promote behavioral change in the workplace.

Following on, Dr. Birka Lehmann, Senior Expert Drug Regulatory Affairs, reviewed the New European Regulation for Clinical Trials, stressing the need for further legislative changes to drive a more harmonized approach by regulatory agencies granting clinical trials and Ethics Committees agreements. Dr. Lehmann outlined the transition with the regulations, which underscore the harmonization of conditions, emphasizing the new challenging interactions needed by regulatory agencies, Ethics Committees, and applicants. New timelines have to be respected by all involved partners. That e-handling of applications and approvals is imperative. Don’t miss the recording.

The panel discussion on Health Economics Outcomes Research, on December 17th,  explored the evolving healthcare landscape and increasing expectations to demonstrate value.  Subscribe to the Academy’s YouTube page to be notified once this recording has been posted.

We express our sincere appreciation for the invaluable inputs and contributions from our expert faculty and hosts. We are encouraged by your active participation at these events and look forward to your continued support and engagement.

IFAPP Academy/MAPS – Introduction to Medical Affairs in Medicines Development Course

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IFAPP Academy/MAPS Introduction to Medical Affairs in Medicines Development Course

IFAPP Academy/MAPS Introduction to Medical Affairs in Medicines Development Course

In April we announced that IFAPP Academy and MAPS (Medical Affairs Professional Society) had partnered up to develop and deliver an online course, “Introduction to Medical Affairs in Medicines Development, ” to be launched this year, 2020.  We are happy to announce that registration for this course is now available! 

This course was designed for the Medical Affairs professional who wants to further learn the fundamentals of Medicines Development and how the various Medical Affairs functions contribute to bringing better medicines to the marketplace, meeting patient needs, and improving health in the general population.

This course was adapted from Module 1 of IFAPP Academy/King’s College London, Medical Affairs in Medicines Development Certification Program. It gathers together experts from the pharmaceutical industry, regulatory agencies, and academic institutions to offer the latest advances in all areas of Medicines Development.  It provides tips for the effective practice of the Medical Affairs function through a state-of-the-art interactive online classroom.

If you are interested in learning more about this new course, you can visit the following link: https://medicalaffairs.org/elearning/introduction-to-medical-affairs-in-medicines-development/

Creating a Professional Identity in Pharmaceutical Medicine and Medicines Development: GFMD

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Creating a professional identity

Professional Identity

The vast majority of professionals created, over the years, a strong image of their professional identity: this happens not only in Life Sciences (where most if not all professionals have a clear identity, like Oncologists, Biotechnologists, Molecular Biologists, among others), but also professionals working in legal matters, economics, physics, et cetera.

Some years ago, while discussing this matter among IFAPP officers, we realized that professionals working in Pharmaceutical Medicine were lacking a Professional title. Indeed, most may identify themselves based on their medical certification (pneumologist, infectiologist), but this title frequently has no more link with their present job role.

Working Group Created

Our discussion was then closed with the unanimous idea that we had to build our professional image of global experts in Pharmaceutical Medicine. According to the IFAPP style, a working group under the leadership of Dr. Honorio Silva, IFAPP Past President and current IFAPP Academy President, was formed to create a professional certification path involving combinations of the postgraduate academic education and continuing professional development along with professional experience and contribution to the fields of Clinical Research and Medicines Development. Three professional certification levels: Certification in Medicines Development (CMD), offered by IFAPP Academy and IFAPP, Specialist in Medicines Development (SMD offered by PharmaTrain and IFAPP) and the Global Fellow in Medicines Development (GFMD, offered by IFAPP Academy and IFAPP with the support of the Faculty of Pharmaceutical Medicine), were formed. A scoring system was created, aimed at evaluating the contribution of each professional based on Education, Contribution to the Profession (presentations, publications, experience, patents), and contributions to the external Awareness of Pharmaceutical Medicine as a discipline for the GFMD.

To our knowledge, this is a unique certification approach organized by biomedical professional associations.

Pilot Experience

The Working Group arranged a pilot experience to assess the accuracy of the criteria for the various domains. They distributed Individual invitations during the 4th Quarter 2019 to a group of selected candidates meeting the above criteria.  A total of 117 applications were submitted, evaluated, and approved. The domains and scoring systems were thus validated. Initially, the award ceremony was to be held during ICPM 2020 (Rome, March 2020), but the event was cancelled due to Covid-19. The ceremony was held virtually on July 16th, 2020. Awardees were invited to join the event and receive their certification.

Looking Ahead

This project is the first step of a long journey.  IFAPP and IFAPP Academy are committed to inviting many more professionals to be part of the community of Global Fellows. We are expecting all members will be involved in a lifetime program of continuous professional growth and contributions to leverage health at national and global levels. Join us in the GFMD community! Be part of an international team devoted to the development of safe and efficacious drugs for the benefit of patients worldwide. More details will be distributed shortly on the process for the identification of the second cohort of GFMD.

Domenico Criscuolo, MD, PhD, GFMD

on behalf of the IFAPP/IFAPP Academy Certification WG

IFAPP Academy Executive team at MAPS Global Conference in Miami

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IFAPP Academy Executive team at MAPS Global Conference in Miami - IfappAcademy.org
From left to right: Honorio Silva (IFAPP Academy CEO), Mary Alice Dwyer (MAPS Chair Executive Program Committee), Jacob Coots (IFAPP Academy Program Manager), Ana Salgado (IFAPP Academy Strategic Director), Susan Hanf (MAPS Manager), Gustavo Kesselring (IFAPP Academy Vice President) and Travis Hege (MAPS CEO)

At the beginning of March, IFAPP Academy’s Executive Team was able to attend the MAPS Global Conference in Miami. The Academy in partnership with MAPS (Medical Affairs Professional Society) will develop and deliver an online course, “Introduction to Medical Affairs in Medicines Development, ” to be launched this year, 2020.

If you are interested in learning more about this new course, sign up for the IFAPP Academy’s Newsletter to receive the latest updates.

Clinical Trial Guidance for use during COVID-19 Pandemic

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Important Clinical Trial Guidance for use during COVID-19 Pandemic

We know that Medical Affairs and Medicines Development Professionals around the world have been working non-stop to develop vaccines, treatments, testing, and medical devices in response to the COVID-19 pandemic. To aide in the distribution of information, we have provided below important clinical trial guidance from different sources for use during this pandemic.

We wish everyone health and safety during this difficult time!

The below document was released by ACRO – Association of Clinical Research Organizations

Considerations to Support Clinical Trial Monitoring Oversight During COVID-19, 13 March 2020

The emerging coronavirus (COVID-19) situation is increasingly impacting clinical trial oversight, particularly on-site monitoring. The Association of Clinical Research Organizations (ACRO) recommends that sponsors, CROs and sites introduce emergency interim measures so that clinical trial monitoring is maintained during this period. These guidelines will ensure that data quality is unaffected, clinical trial sites are supported and that the patients enrolled in clinical trials are kept safe.
The use of centralized monitoring tools and technologies can supplement and support the recommendations outlined below. These practices and tools are already in place and do not require any additional sophisticated analytical tools or dashboards. Care should be taken that any remote monitoring activities implemented are proportionate to the risks identified. Further, they should not place any extra burden on clinical trial sites.

These recommendations should be considered in the following situations:
• When sites have suspended or restricted all visitors (including clinical research associates (CRAs)) from accessing medical facilities, but where patient visits are still occurring
• When local health officials have implemented regional quarantines
• When local CRAs are unable to travel to the sites (for personal health reasons or because of travel restrictions)

Click the following download button to view the entire document: ACRO-Statement-on-Monitoring-Oversight-FINAL-3.13.20Download

The below document was released by the European Medicines Agency (EMA).

Guidance on the Management of Clinical Trials during the COVID 19 (Coronavirus) pandemic Version 1 (20/03/2020)

The European Medicines Agency (EMA), Good Clinical Practice (GCP) Inspectors Working Group, the Clinical Trials Facilitation and Coordination Group (CTFG, a working group of the Heads of Medicines Agency (HMA)), the Clinical Trials Expert Group (CTEG, a working group of the European Commission representing Ethics Committees and National Competent Authorities) and the European Commission (EC) acknowledge the impact of COVID-19 on the health system and broader society, and the impact it may have on clinical trials and trial participants1. Extraordinary measures may need to be implemented and trials adjusted due to e.g. trial participants being in self-isolation/quarantine, limited access to public places (including hospitals) due to the risk of spreading infections, and health care professionals being committed to critical tasks. Therefore, EMA, EC and HMA strongly support the efforts of the GCP Inspectors’ Working Group for developing harmonised EU/EAA-level guidance to mitigate the negative effects of the COVID-19 pandemic on the conduct of clinical trials.

The situation is evolving, and pragmatic actions may be required to deal with the challenges of conducting research, and in ensuring the rights, safety and wellbeing of participants. The points mentioned below are intended to provide guidance for all parties involved in clinical trials during this time.

Due to the urgency, this guidance is issued without prior public consultation. The sponsors should note that due to the rapidly evolving situation further updates to this guidance are possible and likely.

Click the following download button to view the entire document: EMA-guidanceclinicaltrials_covid19_enDownload

The below document was released by the FDA (Federal Drug Administration)

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

Guidance for Industry, Investigators, and Institutional Review Boards (March 2020)

I. Introduction The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support continuity and response efforts to this pandemic.
FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity during the COVID-19 pandemic.

Given this public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.

In general, FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.

Click the following download button to view the entire document: FDA-COVID-19_FDA-17Mar2020Download

Gustavo Kesselring Appointed New CIOMS Executive Committee Member Representing IFAPP

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Gustavo Kesselring Appointed New CIOMS Executive Committee Member Representing IFAPP - IfappAcademy.org
(far right) Dr. Gustavo Kesselring, IFAPP Academy VP with CIOMS group in Geneva

Gustavo Kesselring, MD, IFAPP Academy Vice President & International Affairs, IFAPP, has been appointed CIOMS Executive Committee Member on behalf of IFAPP as of 18 December 2019. As well known, CIOMS (Council for International Organizations of Medical Sciences) is a non-profit organization associated with UNESCO and WHO. The CIOMS mission is to advance public health through guidance on health research including ethics, medical product development, and safety. More information about CIOMS is available at www.cioms.ch.

IFAPP Academy Vice President of External Affairs, Module Chair Gustavo Kesselring

“This is a great honor and a valuable recognition of the global effort IFAPP & IFAPP Academy have been doing in the past years engaging several stakeholders in competency-based education and training in Medicines Development and Pharmaceutical Medicine. By no means, this achievement would have been possible without the teamwork and great contributions done by many colleagues working in academia, pharmaceutical companies, regulatory agencies, and government”, underlined Dr. Kesselring.

Gustavo Kesselring, MD, IFAPP Academy Vice President & International Affairs

The National Institute of Health: All of Us Research Program

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A study that will provide much-needed insight for healthcare providers and pharmaceutical companies, allowing for a truly patient-centric approach with precision medicine.

“The ultimate goal of the All of Us Research Program is to collect information to lead to incredible discoveries in biomedical research and precision medicine, but along the way, we are going to transform lives. We are going to provide opportunities for people that historically have not had the opportunity to participate in research, and I think that’s a really important part of the program, and something that I feel really honored to get to be a part of.”

—Amy Taylor, regional vice president, Community Health Center, Inc.

What is the Precision Medicine Initiative?

The Precision Medicine Initiative (PMI) is a bold research effort to revolutionize how we improve health and treat disease. The PMI aims to leverage advances in genomics, emerging methods for managing and analyzing large datasets while protecting privacy, and health information technology to accelerate biomedical discoveries.

What is the All of Us Research Program?

NIH’s All of Us Research Program is a major piece of the PMI. All of Us will engage one million or more volunteers living in the U.S. to contribute their health data over many years to improve health outcomes, fuel the development of new treatments for disease, and catalyze a new era of evidence-based and more precise preventive care and medical treatment.

The above information, videos, and quotes were provided by the NIH, All of Us website. For additional information please visit: https://allofus.nih.gov/

Future of Medical Affairs: “Third Strategic Pillar”

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“Third Strategic Pillar” of the pharmaceutical industry

medical affairs future

Learn what McKinsey & Company has to say about the future of Medical Affairs, “A Vision for Medical Affairs in 2025”. 

Are you ready for the future of Medical Affairs? In A vision for Medical Affairs in 2025, a new report released by McKinsey & Company, Medical Affairs is cited as the “third strategic pillar”[1], right along with R&D, and commercial & market access1 in the pharmaceutical industry. Essentially, Medical Affairs professionals are no longer acting as the supporting cast, they are now co-starring in the production.

As the pharmaceutical industry evolves and changes, those within it must adapt and develop the skills and competencies needed to address the emerging needs.  Patients and physicians are seeking high-quality and reliable information, products, and services.  Pharmaceutical companies are acknowledging the primary role that Medical Affairs Professionals play in providing this, and ultimately bridging the gap between the company and its stakeholders (physicians and patients).  The need for qualified, competent, and agile Medical Affairs Professionals to fill this primary role within organizations has become apparent.  

Apply now and build your future in medical affairs

The IFAPP Academy/King’s College London, Medical Affairs in Medicines Development, Certification Program provides the training needed for Medical Affairs Professionals to not only become successful in their careers but ultimately provide a higher standard of care and service to patients and healthcare providers.