• Existing Student?   Click Here to Login
IfappAcademy.org
  • WELCOME TOIFAPP ACADEMY
    • WELCOME
    • STRATEGIC ALLIANCE KING’S COLLEGE LONDON
    • VALUE OF CERTIFICATION
    • VALUE OF MEDICAL AFFAIRS
    • HOT TOPICS OF MEDICAL AFFAIRS
  • WHY MEDICALAFFAIRS
    • CORE CAPABILITIES
    • COMPETENCIES
    • WHATS NEW IN MEDICAL AFFAIRS
  • PROSPECTIVESTUDENTS
    • REQUIREMENTS
    • BENEFITS
    • CERTIFICATION, ACCREDITATION, & CREDENTIALING
    • 2021 PROGRAM INFORMATION & APPLICATION
  • PROGRAM
    • PROGRAM DETAILS
    • TIMELINES
    • LEARNING OUTCOMES
  • ABOUT US
    • NEWS FROM IFAPP ACADEMY
    • BOARD OF OFFICERS
    • ADVISORY COUNCIL
    • FACULTY
  • CONTACT US
  • Search
  • Menu Menu
  • Facebook
  • LinkedIn
  • Youtube
  • WELCOME TOIFAPP ACADEMY
    • WELCOME
    • STRATEGIC ALLIANCE KING’S COLLEGE LONDON
    • VALUE OF CERTIFICATION
    • VALUE OF MEDICAL AFFAIRS
    • HOT TOPICS OF MEDICAL AFFAIRS
  • WHY MEDICALAFFAIRS
    • CORE CAPABILITIES
    • COMPETENCIES
    • WHATS NEW IN MEDICAL AFFAIRS
  • PROSPECTIVESTUDENTS
    • REQUIREMENTS
    • BENEFITS
    • CERTIFICATION, ACCREDITATION, & CREDENTIALING
    • 2021 PROGRAM INFORMATION & APPLICATION
  • PROGRAM
    • PROGRAM DETAILS
    • TIMELINES
    • LEARNING OUTCOMES
  • ABOUT US
    • NEWS FROM IFAPP ACADEMY
    • BOARD OF OFFICERS
    • ADVISORY COUNCIL
    • FACULTY
  • CONTACT US
You are here: Home1 / IFAPP Academy

Posts

At IFAPP Academy, our values guide our decisions and actions

December 18, 2020/in What's New at IFAPP Academy /by Amanda Schmitt

IFAPP Academy Values

A discussion around values may be felt unnecessary for those who, like us, are dedicated to healthcare professionals’ education and growth.  But we think it is very timely.

This year, the IFAPP Academy embarked on an ambitious plan, with several initiatives, to get us closer to delivering on our vision to become the center of reference for education in Medical Affairs and Medicines Development — bringing more options for our community of students, our alumni, and our global fellows.

In the midst of the uncertainly, ambiguity, and sadness this year has brought, our values kept us centered and focused on delivering for our students and sponsors, and ourselves, personally, as we had promised.

The values we live by are:

Integrity: Honesty is the only way we know

Productive creativity: We find new and better ways to get things done

Professionalism: We know what we do well, with a zero-defect approach

Partnership:   We know that by going together, the horizon looks closer. 

Global inclusiveness:  We value all voices, backgrounds, and opinions

Scientific Advisory Committee to spearhead IFAPP Academy’s learning outreach ambitions

December 18, 2020/in What's New at IFAPP Academy /by Amanda Schmitt

Building on the phenomenal accomplishments in an exceptionally challenging year, the IFAPP Academy is poised for expanding its global communications outreach in 2021, as the fountainhead in the realm of education and training in medicines development. To champion this cause, the elite cadre of biopharmaceuticals professionals, convened under the banner of an Editorial Board, will be designated as the IFAPP Academy’s Scientific Advisory Committee, to more pertinently reflect the considerably expanded remit and scope of oversight envisaged for a burgeoning global community of learners. In alignment with the IFAPP Academy and IFAPP governance, the Scientific Advisory Committee, chaired by Pravin Chopra, will drive the strategic communications framework and guidance for engaging key stakeholders. The Committee will oversee the Academy’s growing Value-Added Programs and Services offerings, and direct the Academy’s external scientific exchange platforms aspiring to inform, educate, and engender dialogue on trending topics and advancements in biopharmaceutical medicines development and medical affairs. The ongoing pandemic has fueled the imperative for virtual connectivity and networking amongst patient advocates and biomedical professionals, and the Academy gratefully acknowledges the valued expertise, insights, and leadership of the Scientific Advisory Committee members as we enter a new era of healthcare innovation.

Building on the phenomenal accomplishments in an exceptionally challenging year, IFAPP Academy is expanding its global communications outreach in 2021 as the fountainhead in education and training in medicines development.

To champion this cause, the elite cadre of biopharmaceuticals professionals convened under the banner of an Editorial Board.  The board was designated as IFAPP Academy’s Scientific Advisory Committee to reflect the considerably expanded remit and scope of oversight envisaged for learners’ burgeoning global community.

In alignment with IFAPP Academy and IFAPP governance, the Scientific Advisory Committee, chaired by Pravin Chopra, will drive the strategic communications framework and guidance for engaging key stakeholders. The Committee will oversee the Academy’s growing Value-Added Programs and Services offerings and direct the Academy’s external scientific exchange platforms aspiring to inform, educate, and engender dialogue on trending topics and advancements in biopharmaceutical medicines development and medical affairs.

The ongoing pandemic has fueled the imperative for virtual connectivity and networking amongst patient advocates and biomedical professionals, and the Academy gratefully acknowledges the valued expertise, insights, and leadership of the Scientific Advisory Committee members as we enter a new era of healthcare innovation.

IFAPP Academy in 2020: another year of continuing success!

December 18, 2020/in What's New at IFAPP Academy /by Amanda Schmitt
IFAPP Academy Team in action

IFAPP Academy Team at work

IFAPP Academy is a nonprofit organization incorporated in the USA as the educational arm of IFAPP, with the mission of proving, communicating, and achieving recognition of the contributions of Medical Affairs functions to leverage health care as well to establish  Medicines Development as a distinct biomedical profession through the related certification achieved through our education and training programs.

IFAPP Academy fosters the necessary collaborations and partnerships among stakeholders to ensure competent professionals are responsible for bringing the right medicines to the right patients.

Despite the tragic circumstances related to the pandemic, 2020 has been a year of consolidation of the IFAPP Academy with impressive outcomes in term of academic achievements, strategic alliances, and new educational programs, which can be summarized as follows:

  • Continuing interannual growth in the core IFAPP Academy-King’s College London program: The 2020 cohort includes around 130 students from 54 countries who completed the 6 modules and are expected to get the formal certification by year-end. Almost 400 certified alumni from 4 annual cohorts represent the output of our academic operations.
  • Successful launch of the Course on Leadership in Medical Affairs, developed in collaboration with Tufts University Center for Studies in Drug Development, including 63 students. Like the Core Program above, this fully online program’s feedback has been particularly outstanding in terms of satisfaction and observed behavioral changes.
  • Successful launch of the Introductory Course on Medical Affairs in Medicines Development developed in collaboration with MAPS (Medical Affairs Professional Society). This was a novel approach for synergies among professional organizations. Again, metrics for knowledge gain and student satisfaction are impressive.
  • Launching of the Global Fellows in Medicines Development Award: developed in collaboration with IFAPP and the Faculty of Pharmaceutical Medicine. This is a new approach for Certification for biomedical professionals to acknowledge the contributions to Pharmaceutical Medicine as a discipline and profession in several domains (academic, science, innovations, external recognition, etc.). The first cohort included 117 distinguished pharmaceutical physicians and investigators from 24 countries who are charged with the five C’s as follows:
    • Champion: Foster Pharmaceutical Medicine as an established profession.
    • Communicate: Create awareness of this award’s intrinsic value.
    • Connect:  Help identify and recruit the next cohort of Global Fellows.
    • Cultivate: Join an IFAPP member association (or IFAPP directly) and support its activities.
    • Collaborate: contribute to or participate in the Value-Added Programs.
  • Launching of the IFAPP Academy Value Added Program: To serve our growing community and the IFAPP membership with CPD activities (newsletter, webinars, interviews, etc.) on hot topics related to medicines development. The “Conversations with the Academia” webinar program has elicited considerable attention and positive feedback since its inception.
  • Launching of the IFAPP Academy Values, guiding our business and academic operations which can be summarized as follows:
    • Integrity: Honesty is the only way we know
    • Productive creativity: We find new and better ways to get things done
    • Professionalism: We know what we do well, with a zero-defect approach
    • Partnership: We know going together, the horizon looks closer.
    • Global inclusiveness: We value all voices, backgrounds, and opinions

      IFAPP Academy Team in celebration

      IFAPP Academy team celebration

The perspectives for 2021 are also highly encouraging. A set of new programs and plans for a career path in Medicines Development are under preparation and will be shared early next year.

These extraordinary achievements can only be explained by the commitment, teamwork, and proven competence of our IFAPP Academy Board of Directors, the IFAPP Academy Operations Team, and the Advisory Council with our sponsors’ continuous support. We are indebted and thankful for their efforts and ceaseless dedication to achieve our mission.

 

IFAPP Academy President, Dr. Honorio SilvaHonorio Silva, MD GFMD FFPM (Hon)

President, IFAPP Academy Inc

Past President, IFAPP (International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine)

Director, IFAPP-King’s College Professional Certification Program on Medicines Development

IFAPP Academy’s New Editorial Board

October 28, 2020/in What's New at IFAPP Academy /by Amanda Schmitt
Read more

Introductory Note from IFAPP Academy’s President

October 28, 2020/in What's New at IFAPP Academy /by Amanda Schmitt
Read more

Looking for a world-class, online Certification Program in Medicines Development? Look no further!

October 25, 2020/in What's New at IFAPP Academy /by Amanda Schmitt
Read more

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

August 10, 2020/in What's New at IFAPP Academy /by Amanda Schmitt
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/

Global Fellow in Medicines Development Award Ceremony

August 4, 2020/in What's New at IFAPP Academy /by Amanda Schmitt

Global Fellows in Medicines Development

 

IFAPP and the IFAPP Academy worked together on the idea of fostering certification and recognition which would reflect the professional identity of experts in Medicines Development: this process moved the first steps in 2019, with the formation of a Working Group including representatives from IFAPP, the IFAPP Academy, PharmaTrain and the Faculty of Pharmaceutical Medicine, who were able to identify about 150 professionals and to invite them to join the initiative. The invitation was warmly welcomed by most of the addressees, who provided their educational, professional, and scientific backgrounds, which indeed satisfied the criteria to receive the award of Global Fellow in Medicines Development.

A digital Global Fellow Award Ceremony was held on 16 July 2020 to recognize those individuals who made significant contributions to the advancement of Pharmaceutical Medicine whilst serving in the biopharmaceutical industry, government, regulatory agencies, clinical research sites, academic institutions or CRO.

What is a Global Fellow

In the words of Professor Peter Stonier, Professor of Pharmaceutical Medicine at King´s College (London), the goal of this award is to create a global network of experts which would help to advance Pharmaceutical Medicine as summarized in the following five C’s:

  • Champion: Foster Pharmaceutical Medicine as an established profession;
  • Communicate: Create awareness of this award’s intrinsic value;
  • Connect: Help identify and recruit the next cohorts of Global Fellows;
  • Cultivate: Join an IFAPP member association (or IFAPP directly) and support its activities;
  • Collaborate: contribute to or participate in the Value-Added Programs.

Global Fellow in Medicines Development Award Ceremony - IfappAcademy.org

Dr. Honorio Silva, one of the organizers of the event, summarized the steps which will lead to the title of Global Fellow in Medicines Development, gave also an overview of the meaning of being a Fellow, and closed the ceremony underlining that the first cohort of Global Fellows in Medicines Development is made of 117 professionals from 24 different countries: a real global community!

 

 

 – Domenico Criscuolo, MD, PhD, GFMD and Gustavo Kesselring MD, GFMD

IFAPP Academy Executive team at MAPS Global Conference in Miami

April 1, 2020/in What's New at IFAPP Academy /by Amanda Schmitt
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

April 1, 2020/in Hot Topics in Medical Affairs /by Amanda Schmitt
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

Page 1 of 512345
  • News from IFAPP Academy
  • Hot Topics of Medical Affairs – IFAPP Academy

Newsletter

Archives

IFAPP Academy provides an online, continuing professional development course, Medical Affairs in Medicines Development, resulting in the Professional Certification, Certified Medicines Development (CMD).

 Site Map | Contact Us |Privacy Policy | Cookies
© Copyright - IfappAcademy.org - powered by Enfold WordPress Theme
  • Facebook
  • LinkedIn
  • Youtube
Scroll to top