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ICPM 2018 presents the IFAPP Academy, Medical Affairs in Medicines Development, Program Graduates

News from IFAPP Academy

ICPM 2018 presents IFAPP Academy Graduates

What is ICPM?

The International Conference of Pharmaceutical Medicine (ICPM) is the largest event for the International Federation of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP).

ICPM is held every two or three years and is aimed to provide state of the art information in key areas for our discipline and profession. ICPM 2018 was held in Tokyo, September 27th – 29th, (www.icpm2018tokyo.com) in collaboration with the Japanese Association of Pharmaceutical Medicine (http://www.japhmed.org) and brought together around 400 representatives from the pharmaceutical, clinical research, and regulatory arenas from all over the world.


Gustavo Kesselring, MD International Affairs, IFAPP

“Attending the International Conference of Pharmaceutical Medicine (ICPM) is an outstanding opportunity to learn about the news trends in pharmaceutical medicine and medicines development, besides networking with world class faculty from academia, pharmaceutical companies, and government officials in a friendly environment.

Since 2006, in Seoul, I have attended all ICPMs. Being in Tokyo this year, attending the latest ICPM, I am still thrilled about how Pharmaceutical Medicine can motivate people from all parts of the world to get together and discuss the Future of Medicines Development. Hope you don´t miss the ICPMs in the coming years.”


Dr. Marcos O. Perez III receiving his CMD Certificate

Dr. Marcos O. Perez III receiving his CMD Certificate

From left to right: Drs. Gustavo Kesselring, Warachal Eileen Faison (with CMD Certificate), and Honorio Silva

From left to right: Drs. Gustavo Kesselring, Warachal Eileen Faison (with CMD Certificate), and Honorio Silva

Dr. Honorio Silva Introduces the Graduates from the IFAPP Academy Program

Students graduating from the Program were invited to attend ICPM 2018 in Tokyo. Although not all of the students were able to make the trip for the ceremony, Dr Honorio Silva honored each of them through a presentation that included their pictures, job titles, and affiliations.

The students that were able to attend the ceremony were provided free admittance into the conference and presented with their Certificate in Medicines Development (CMD) during the awards ceremony, held the first day of the conference.

Want to learn more about the IFAPP Academy?

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.

The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course.

Click here for more information! Applications are now being accepted for the 2019 Cohort. Application deadline is Dec. 1st, 2018

Get to know the students of the IFAPP Academy!

News from IFAPP Academy


Get to know the students of the IFAPP Academy!

Meet Asmaa Salah Abdel Khalek, a Clinical Trial Evaluator and Auditor at the EDA, the Egyptian Drug Authority.

The IFAPP Academy is proud to provide continuing professional development to Medical Affairs Professionals worldwide. This month, we would like to introduce you to, Asmaa Salah Abdel Khalek, a current student of the IFAPP Academy/King’s College, Medical Affairs in Medicines Development, Certification Program.

Asmaa Salah Abdel Khalek, Clinical Trial Evaluator and Auditor, EDA

What is your name and job title?

I’m Asmaa Salah Abdel Khalek, Clinical Trial evaluator and auditor at the EDA, the Egyptian Drug Authority.

What do you feel is your greatest achievement?

My greatest achievement could be simplified in my dream to improve the clinical trial regulation in my country, to cope with the international guidelines.

Currently, I’m working in the national NRA and due to my continuous search and education in the clinical research field, I can see a lot of obvious gaps in the regulations of the clinical trials in my country. I truly hope to be one of the team that will standardize and unify the clinical trial regulations which will have a great impact on the provided pharmaceutical services across all the different healthcare sectors. You start to improve the moment you figure out the weak points and work on them.

What is your favorite hobby and/or activity outside of your work?

My favorite hobby is walking in an open area, listening to my favorite music.

What do you enjoy most about being a Medical Affairs Professional?

First, it was a great honor for me to hear about the medical affairs professional degree provided by IFAPP. I’m totally interested in this specialty which is now the direction of all the huge pharmaceutical companies.  Working in a patient-centered approach, integrating the medical affairs specialists as key members along the entire product lifecycle.  Through a mutual collaboration with all the company staff, starting from studying the market to detecting the medical needs, aiming to meet these needs, then helping the academic scientists to deliver their basic research and input, to shift from bench to lab, and then the huge massive clinical trial initiation, and monitoring, regulatory approval and marketing authorization, marketing plan starting from studying the market, targeting the main stakeholder, positioning etc.…. followed by the post-marketing and outcome research studies that may help to support the product value. Medical affairs is a broad concept, it could be an MSL, CRA, marketing team, regulatory affairs and so much more.

This is a new direction with a great impact, improving the performance. And for me, I’m completely interested in the clinical research sections and regulation pre and post-marketing authorization.

What has been the most beneficial aspect of the IFAPP Academy Program?

The most beneficial aspect of the IFAPP Academy Program is its professional organization which truly helped me to make a complete picture of the medical affairs profession.  Also, the lecturers, listening to these lectures from professional professors who already have a great experience and are completely updated in that field was very helpful. Lastly, the rich content and the flexibility of the program.

How has your view of the medical affairs profession altered and/or improved?

The medical affairs profession altered to be patient-centered and improved to make a great progress across all the product lifecycle, integrating with all other sectors in the company.

Any additional comments that you would like to make about the IFAPP Academy/King’s College, Medical Affairs in Medicines Development, Certification Program?

I would like to say thank you to all the IFAPP team and the program director for their patience and the great support they presented to us in this great program.

Thank you, Asmaa! The Academy looks forward to seeing your many great achievements and contributions to the Medical Affairs arena.

Want to learn more about the IFAPP Academy?

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.

The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Click here to learn more about the benefits of Professional Certification from the IFAPP Academy.

A historical reminder of the importance of Regulatory Affairs in Medicines Development

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A historical reminder on the importance of Regulatory Affairs in Medicines Development

As the IFAPP Academy is gearing up for students to start Module 5: Regulatory Affairs, Drug Safety, and Pharmacovigilance we are reminded of the importance of these regulatory bodies and the need for continued oversight in medicines development.  The FDA emphasizes this with a short video about what can happen when medicines are not being properly regulated.

https://www.youtube.com/watch?v=mrYFbPf5qsM

Want to learn more about medicines regulations within medicines’ development?

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.

The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Click here to learn more about the benefits of Professional Certification from the IFAPP Academy.

The IFAPP Academy’s Core Competencies are truly ‘the Core of Medical Affairs’

News from IFAPP Academy


The IFAPP Academy’s Core Competencies are truly ‘the Core of Medical Affairs’


Core Competencies of Medical Affairs

The IFAPP Academy/King’s College, Medical Affairs in Medicines Development, 2018 Cohort is finishing up Module 4 exams, starting this week. This means there are only 2 Modules remaining before the End of Program Assessment, to culminate in the Certification of this year’s qualifying students. Students successfully completing the program will be able to use the post-nominal letters CMD as a designation of their earned competencies.

The IFAPP Academy Core Competencies align with the McKinsey & Co report on the Core Capabilities of Medical Affairs Professionals.

MCKINSEY & CO CORE CAPABILITIES IN MEDICAL AFFAIRS
IFAPP STATEMENT OF COMPETENCE IN MEDICINES DEVELOPMENT
Scientific and technological leadership
and strategic vision
Can identify unmet therapeutic needs, evaluate the evidence for a new candidate for clinical development and design a Clinical Development Plan for a Target Product Profile.
Scientific and technological leadership
Can design, execute and evaluate exploratory and confirmatory clinical trials and prepare manuscripts or reports for publication and regulatory submissions.
Learning agility
Can interpret effectively the regulatory requirements for the clinical development of a new drug through the product life-cycle to ensure its appropriate therapeutic use and proper risk management.
Deep understanding of compliance
Can evaluate the choice, application, and analysis of post-authorization surveillance methods to meet the requirements of national/international agencies for proper information and risk minimization to patients and clinical trial subjects.
Strategic vision & scientific leadership
Can combine the principles of clinical research and business ethics for the conduct of clinical trials and commercial operations within the organization.
Deep understanding of compliance
Can appraise the pharmaceutical business activities in the healthcare environment to ensure that they remain appropriate, ethical and legal to keep the welfare of patients and subjects at the forefront of decision making in the promotion of medicines and design of clinical trials.
Emotional intelligence and communication skills
Emotional intelligence and communication skills

According to McKinsey & Co. (Evers, et al., 2014), “the bar is high for Medical Affairs talent. They need to collaborate with R&D colleagues and deeply understand the science that underpins their work; they must understand the rules and regulations governing the industry almost as well as their compliance and legal department colleagues; and they should have the strategic thinking capabilities of their marketing counterparts as well as the customer-interaction skills of their colleagues in sales.”

IFAPP Academy students gain the necessary knowledge and understanding to create patient-centric environments where they can interact with a broad range of stakeholders to provide a more tangible value to patients. This has become increasingly important as “the right talent is often scarce, especially at the local country level.” The IFAPP Academy is proud to help fill this gap by providing online Continuing Professional Development for Medical Affairs Professionals.

For more information and to apply for the 2019 IFAPP Academy/King’s College, Medical Affairs in Medicines Development Certification Program click here.

References

Evers, M., Edd, F., Ghatak, A., Hartmann, J., Westra, A., Nathoo, A., . . . Suresh, B. (2014, July). Pharma Medical Affairs: 2020 and beyond. Retrieved July 18th, 2018, from McKinsey & Co.: https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/pharma-medical-affairs-2020-and-beyond#0

3 Reasons why medical affairs professionals need to be savvy with social media

Hot Topics in Medical Affairs


3 Reasons why medical affairs professionals need to be savvy with social media.



The worldwide reach of social media has changed how people communicate. Social media platforms are becoming the go-to source for communication.  Patients are more likely to share their medication side effects, such as the itchy rash they got on their butt or the achy joints that prevented them from playing golf with friends, on social media than to their doctor. Social media channels not only have the potential to act as a way of reporting adverse events but also help companies understand the wants and needs of patients.

Therefore, with the ever-increasing importance of patient centricity and personalized medicines, more and more companies are relying on social media to provide them with answers. These are just some of the many ways that companies are leveraging social media.

1.  Creating a truly patient-centric approach

“There has been a lot of talk in recent years of a need to increase patient-centricity within the pharmaceutical industry. Indeed, there have been many great steps towards a more patient-centric approach, and a greater recognition of the value of patient choice and the need for increased self-management across healthcare systems” (Rees, Sumira, & Morton, 2018).  However, to put this into practice companies must provide patients with the necessary tools and education. Companies are now relying on data from social media sites to help them learn how to provide patient-friendly information.  “Listening to social conversation can add layers of insights. Online conversations can uncover valuable insights about the audience, whether this be patients, healthcare professionals or key opinion leaders.” (Rees, Sumira, & Morton, 2018)

[caption id="attachment_2000" align="aligncenter" width="845"] Figure 1 Sciformix Corp. “The Impact and Use of Social Media in Pharmacovigilance”

2. Product Vigilance (PV)

In a whitepaper by Sciformix, “social media has the potential to become an added new-age tool to monitor data in real-time, making it an early indicator of potential safety issues for further investigation. Further, this would enable companies to generate more robust product safety profiles by leveraging the additional social media information” (Sciformix Corporation).

3.  Clinical trial recruitment

According to Medrio.com, “Social media has the potential to be a powerful tool in the clinical trial recruitment process because of its low cost and ability to reach a diverse and broad audience. In 2014, Facebook boasted over 1.2 billion monthly active users, Twitter had 255 million, LinkedIn was at 187 million.  These numbers outweigh the traditional recruiting numbers in every way.  This capability is something that one-sided print/TV ads or even clinician/patient referrals cannot provide: access to diverse cultures, age groups, gender, and income levels” (Medrio, 2015).


Want to learn how to expand your skillset and continue your professional development in Medical Affairs?

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals.

The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Click here to learn more about the benefits of Professional Certification from the IFAPP Academy.


 

References

Medrio. (2015, August 6). Using Social Media to Recruit Subjects in Phase I Clinical Trials. Retrieved from Medrio: https://medrio.com/blog/using-social-media-to-recruit-subjects-in-phase-i-clinical-trials/

Rees, N., Sumira, D., & Morton, A. (2018, June 13th). The Patient Journey. Retrieved June 19, 2018, from PM LiVE: http://www.pmlive.com/pharma_thought_leadership/the_patient_journey_1239641

Sciformix Corporation. (n.d.). The Impact and Use of Social Media in Pharmacovigilance. Retrieved June 19, 2018, from Sciformix: https://www.sciformix.com/wp-content/uploads/Social_Media_in_PV_Whitepaper.pdf

World Pharma News. (2017, October 9). Social Media in the Pharmaceutical Industry. (SMi Group) Retrieved June 6, 2018, from World Pharma News: http://www.worldpharmanews.com/events/4139-social-media-in-the-pharmaceutical-industry

What are the benefits of earning a professional certification?

Hot Topics in Medical Affairs


What are the benefits of earning a professional certification?

Despite the career, employees from construction to IT to Pharmacy have found enormous advantages in obtaining a professional certification within their field. Here are 5 advantages of earning professional certification.



  1. Gain a competitive edge. Because let’s face it, competition can be stiff when it comes to the job market. Whether you’re applying for a new job, wanting to be considered for a promotion, or crossing your fingers for an end-of-year raise a professional certification will help to distinguish you from the pack. When considering two individuals with similar backgrounds, a professional certification may get your resume that second look. Certifications can differentiate you from other professionals in your field or company, showing that you have a demonstrated commitment to understanding and excelling in your profession and a desire to learn more.[1]

2.  Increased competency. The success of a team depends on the knowledge and experience of each of its members, which is why professional certifications have become increasingly important in the field of medicine.[2] After all, the primary criteria for employers is to have professionals on their team that are up-to-date with industry standards, norms, and best practices which are in a constant state of flux.[3] E-learning allows providers, such as the IFAPP Academy, to provide the most current and relevant information in an accessible, convenient, and cost-effective manner.

3. Professional credibility. Earning a certification provides immediate credibility with employers and colleagues. Who is going to question a Cisco Certified Internetwork Expert (CCIE), a Microsoft Certified Solutions Expert (MCSE) or a Red Hat Certified Architect (RHCA)? Earning a certification from an internationally recognized organization demonstrates your dedication and motivation to professional development. Many companies will actively support their employees in earning these certifications that may even lead to promotions and raises.[4]

  1. Networking opportunities. Working hard to earn a certification allows you to join a unique group of certified and skilled professionals that share similar goals and ambitions. This can prove to be an invaluable peer resource group that can be a boon when looking for answers to a particularly tough problem or when moving from one company to another. The IFAPP Academy encourages students to network and learn from each other through the student forums and live interactive webinars, providing additional viewpoints from an international perspective.

5.  Increased confidence, because confidence is KEY! In a study conducted by the University of Melbourne, Participants were asked to describe their level of confidence at primary school, high school, university, and present day. Those who self-reported higher levels of confidence earlier in school earned better wages and were promoted more quickly.  Lead author Dr. Reza Hasmath, from the University’s School of Social and Political Sciences, said the research demonstrates a crucial ingredient of workplace advancement.  “The implications are tremendous in terms of the personality employers should look for when it comes to hiring or promoting staff,” Dr. Hasmath said.”[5]

Want to learn how to earn a Professional Certification in Medicines Development in Medical Affairs?

The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) Academy provides online Continuing Professional Development for Medical Affairs Professionals, resulting in the Professional Certification, CMD (Certified Medicines Development).

The IFAPP Academy is a non-profit organization whose mission is to promote, develop, and implement educational activities that support Pharmaceutical Medicine by enhancing the knowledge, expertise, and skills of pharmaceutical physicians and medicines development scientists worldwide. Partnered with King’s College London, the Academy offers Professional Certification for students successfully completing the course. Click here to learn more about the benefits of Professional Certification from the IFAPP Academy.

Resources/References

[1] Laurinavicius, T. (2017, December 07). Why Online Certifications Are Key To Professional Success. Retrieved March 28, 2018, from https://www.huffingtonpost.com/tomas-laurinavicius/why-online-certifications_b_11081630.html

[2] Rewards of Certification. (n.d.). Retrieved March 28, 2018, from https://www.bpsweb.org/impact-of-bps-certification/rewards-of-certification/

[3] Laurinavicius, T. (2017, December 07). Why Online Certifications Are Key To Professional Success. Retrieved March 28, 2018, from https://www.huffingtonpost.com/tomas-laurinavicius/why-online-certifications_b_11081630.html

[4] 10 Benefits of IT Certification for You (and Your Employer). (n.d.). Retrieved March 28, 2018, from https://www.globalknowledge.com/us-en/content/articles/10-benefits-of-it-certification-for-you-and-your-employer/

[5] Hasmath, D. (2012, October 18). Self-confidence the secret to workplace advancement. Retrieved April 09, 2018, from http://newsroom.melbourne.edu/news/self-confidence-secret-workplace-advancement

King’s College London: “From Molecules to Medicines”

News from IFAPP Academy


King’s College London: From Molecules to Medicine

King’s College London, IFAPP Academy’s academic partner, has a strong tradition in pharmaceutical science.

King’s College London has a strong tradition in pharmaceutical science, world-class pharmacology, clinical pharmacology, and therapeutics. This has led to the creation of a number of spin-out companies, including MedPharm and Proximagen Neuroscience plc.

The School of Cancer and Pharmaceutical Science was created to bring together the relevant research groupings across King’s College London.

Molecules to Medicine’s strategy is designed to capture and highlight the broad sweep of research at King’s ranging from pharmacological and chemical studies that can identify novel drug targets and new chemical entities, through formulation and drug development, to clinical trials and the use of medicines by patients. The all-embracing strategy is for researchers to work together towards the discovery of novel medicines and new formulations that can be evaluated in patients in the clinic.

To achieve this goal, and to provide focus, research activities are organized into three related themes: Drug Discovery, Medicines Development, and Medicines Use. Each of these themes includes clusters of research activity, some of which have evolved during the past decade (e.g. drug delivery, chemical biology, pharmaceutical biophysics, pharmacology), and some of which have joined King’s more recently such as enhanced activity in anticancer and anti-infective drug discovery, nanomedicines, substance abuse, health psychology, and clinical pharmacy. Researchers within and across the three themes interact both informally and via joint initiatives to promote cross-disciplinary research. For example, the drug delivery activities of Forbes, Jones, and Daily, working closely with colleagues in pharmacology (Page/Spina) have led to consortium funding and several Ph.D. studentships from the MRC to investigate the safety of nanoparticles in the airways.

This excerpt was originally published on the King’s College website at https://www.kcl.ac.uk/lsm/research/divisions/ips/about/index.aspx

The IFAPP Academy in partnership with King’s College London offers Academic and Professional Certification for students successfully completing the Medical Affairs in Medicines Development course. To learn about the benefits of Certification from the IFAPP Academy, visit us at https://ifappacademy.org/index.php/ifapp-academy-benefits/

Professor Peter Stonier, Co-director of the Medical Affairs Certification program says: