CERTIFICATION PROGRAMS

Certification in Medicines Development

In Partnership with King’s College London

Medical Affairs and Medicines Development are constantly evolving. Those who choose this career will have to meet ever-greater demands and expectations. As a Medical Affairs professional you rise to the challenge of negotiating the complex relationships within the medical community between therapeutic specialties, patient groups, regulatory authorities, device manufacturers, and the pharmaceutical industry. You are challenged to a higher level of communication skills and to wield next-level knowledge of the intricacies of data-driven insights to ensure compliance, manage medical information, and generate medical evidence.

IFAPP Academy developed its certification to better prepare those who are seeking a competency-based education with a curriculum that aligns with the today’s evolving industry standards.

IFAPP Academy-King’s College London Medical Affairs in Medicines Development Certification Program

This program is a unique partnership between academia, industry, and professional associations aimed to foster competencies and improve performance in medical affairs and medicines development. It is anchored by a strategic collaboration between IFAPP (International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine) and King’s College London, one of the world’s leading research and teaching universities based in the heart of London.

The Certification in Medicines Development is ideal if:

You are currently working in, or looking to transition into Medical Affairs

You want to gain invaluable knowledge of Medicines Development and learn from leading global industry experts

You are a biomedical professional seeking to increase your visibility at your company

Program Benefits

Benefits to Program Graduates

  • Greater understanding of the complexity of medicines development
  • Contribute to the sense of purpose for biomedical professionals
  • Enhanced job performance
  • Leverage problem-solving skills
  • Improved preparedness in response to industry trends, opportunities, and challenges

Benefits to Employers

  • Professionals with acquired core competencies that enrich the biopharmaceutical industry and contribute to the business
  • Certified professionals to deliver better medicines and their appropriate usage
  • Stakeholders assurance of competence and professionalism among graduates

Program Overview

The program in total is 10 months long, from January through October every year. Students are expected to complete 6 modules that are 6 weeks long each. The estimated time commitment is 5-12 hours per week.

Online lectures

Time commitment per week: 2-4 hours

  • Two (2) one-hour lectures per week
  • Lectures are released each week for five weeks
  • Completion of all released lectures is required for full credit
  • Lectures can be viewed asynchronously once released
  • A downloadable Lecture reference guide is also provided

Weekly 
Assignments

Time commitment per week: 2-5 hours

  • Forum discussions and learning activities
  • Contributions to discussion forums are graded
  • Interaction with peers and faculty

Webinar / Tutorials with Live Participation

Time commitment per week: 1 hour

  • Required dates and times will be emailed each week
  • Attendance required during specified dates and times
  • Participation in the webinars will be assessed

Assessments

  • Each module will end with a multiple-choice questionnaire exam (MCQ)
  • End of program assessment (EPA) with essays

Program Modules

Introduction to Medical Affairs in Medicines Development

You will learn the value of the Medical Affairs function in the lifecycle of a pharmaceutical product. This module will take you through fundamentals of clinical pharmacology, health economics, exploratory and confirmatory clinical development and clinical research, regulations, and long-term safety, including the emerging role of patients and contributions of the Medical Affairs function in these arenas.

Medical Affairs and Health Economics

This module will focus on how Medical Affairs functions as an effective interface with external and stakeholders to ensure the right medicines are available for patient access and proper use. You will explore the processes involved in the evidence generation health economics and commercialization, as well as the application of digital technologies to ensure the candidate compound meets the desired profile to achieve regulatory approval and rapid entry into the healthcare system across countries.

Drug Discovery, Exploratory and Confirmatory Development

In this module the scientific approach of drug discovery, biopharmaceutical formulation and non-clinical safety evaluation together with the early and confirmatory human trials of drugs and vaccines are covered. The discussion of the statistical evaluation of the results and their contribution to the principles of evidence-based medicine completes the program. 

Clinical Trials – From Concept to Clinical Study Report

In this module you will learn the process to conduct a quality clinical trial. This module will look at ethics, subject protections, quality management, and overall governance. You will also learn the procedures supporting good data collection and management, and budgeting practices. And we will conclude discussing issues related to failures in clinical trials and the latest approaches of decentralized trials. The learning outcomes of this module will be an overall understanding of the process to plan, design, implement, monitor, and report clinical trials.

Regulatory Affairs, Drug Safety and Pharmacovigilance

This module will focus on the regulatory framework of medicines and medical devices development and approval in the US, EU, and the emerging economies. The module will also cover global initiatives for harmonization (e.g. ICH) and highlight some key topics of interest (e.g. specialized regulatory procedures) and their role in the overall regulatory strategy. Risk management and safety reporting will be evaluated from the vantage point of the life cycle of a medicine.

Medical Affairs as a Strategic Business Partner: Adding Value, Accelerating Performance, and Increasing Relevance

This final module will cover the new role of Medical Affairs professionals as a strategic pillar in pharmaceutical business. You will learn the ethics needed working in multidisciplinary clinical research or therapeutic teams, the role of patients and professional organizations in health care, how to address and improve organizational performance, the role of medical affairs in medical education, the importance of quality management, the value of strategic alliances and how to critically review a clinical research paper.

Introduction to Medical Affairs in Medicines Development

You will learn the value of the Medical Affairs function in the lifecycle of a pharmaceutical product. This module will take you through fundamentals of clinical pharmacology, health economics, exploratory and confirmatory clinical development and clinical research, regulations, and long-term safety, including the emerging role of patients and contributions of the Medical Affairs function in these arenas.

Medical Affairs and Health Economics

This module will focus on how Medical Affairs functions as an effective interface with external and stakeholders to ensure the right medicines are available for patient access and proper use. You will explore the processes involved in the evidence generation health economics and commercialization, as well as the application of digital technologies to ensure the candidate compound meets the desired profile to achieve regulatory approval and rapid entry into the healthcare system across countries.

Drug Discovery, Exploratory and Confirmatory Development

In this module the scientific approach of drug discovery, biopharmaceutical formulation and non-clinical safety evaluation together with the early and confirmatory human trials of drugs and vaccines are covered. The discussion of the statistical evaluation of the results and their contribution to the principles of evidence-based medicine completes the program. 

Clinical Trials – From Concept to Clinical Study Report

In this module you will learn the process to conduct a quality clinical trial. This module will look at ethics, subject protections, quality management, and overall governance. You will also learn the procedures supporting good data collection and management, and budgeting practices. And we will conclude discussing issues related to failures in clinical trials and the latest approaches of decentralized trials. The learning outcomes of this module will be an overall understanding of the process to plan, design, implement, monitor, and report clinical trials.

Regulatory Affairs, Drug Safety and Pharmacovigilance

This module will focus on the regulatory framework of medicines and medical devices development and approval in the US, EU, and the emerging economies. The module will also cover global initiatives for harmonization (e.g. ICH) and highlight some key topics of interest (e.g. specialized regulatory procedures) and their role in the overall regulatory strategy. Risk management and safety reporting will be evaluated from the vantage point of the life cycle of a medicine.

Medical Affairs as a Strategic Business Partner: Adding Value, Accelerating Performance, and Increasing Relevance

This final module will cover the new role of Medical Affairs professionals as a strategic pillar in pharmaceutical business. You will learn the ethics needed working in multidisciplinary clinical research or therapeutic teams, the role of patients and professional organizations in health care, how to address and improve organizational performance, the role of medical affairs in medical education, the importance of quality management, the value of strategic alliances and how to critically review a clinical research paper.

IFAPP Academy’s Faculty

Our programs are taught by world-renowned faculty.

Meet Our Faculty Meet Our Faculty

Application Requirements

A successful prospective student profile:

Graduate/postgraduate education in biomedical sciences
Proven command of the English language
One year of experience in the biopharmaceutical industry and/or medicines development activities
Commitment to spend 5-12 hours weekly for home study related to each lecture
Aspiration to grow in the Medical Affairs function
Willing to participate in synchronous webinars (4 per module – 6 modules total per year)
PROGRAM TUITION

The total tuition for our program is $9,600.

Flexible payment plans and financial assistance are available. Tuitions range from $4,800 to $9,600.

See special pricing
The last day to apply for the 2022 academic year is December 6, 2021.

FAQs

What should I expect after completing the Certification in Medicines Development?

The certification program will afford you the opportunity to build strategic relationships with regulatory, clinical, and research professionals, as well as industry leaders and academic experts from around the world. Your dedication and long-served perseverance in completing certification requirements will afford you the privilege of using the CMD post-nominal letters telling your peers and leaders that you are equipped to navigate the complexities of Medicines Development. An ability that will allow you to shine and secure opportunities to drive teams that develop the medicines that bring better healthcare to the world.

What are the educational standards met by this certification program?

The curriculum aligns with the Statement of Competence for Pharmaceutical Physicians and Medicines Development Scientists created for the Innovative Medicines Initiative (IMI) project by IFAPP and PharmaTrain. The IFAPP-PharmaTrain core competencies, together with the PharmaTrain Syllabus, serve as a guide to the IFAPP member associations and related institutions worldwide in developing postgraduate, and CPD programs in pharmaceutical medicine/medicines development science. We believe this certification will allow you to stay ahead of the curve whether working in, or looking to move into, the pharmaceuticals, academia, or regulatory areas.

Is there financial assistance or special pricing?

IFAPP National Member Association (NMA)

TUITION

$7,600

Applicants must provide a letter of recommendation from their National Member Association that includes the applicant’s current membership status.

King’s College London

TUITION

$8,600

Requires personal invitation code from King’s College London.

For more information, please visit:
https://ifappacademy.org/application/

Regulatory/Government Agency Employees

TUITION

$4,800

Applicants must provide the following:

  • Letter of Intent
  • One letter of recommendation from a supervisor that includes employment status
  • Applicant must meet minimum student entry requirements as described above.
  • Limited to 5 students or 5% of the final number of new attending students

Self-paid students 2022

TUITION

$4,800

If you are challenged to afford the full base program fee you can apply as follows:

  • Applicants must not be employed by a pharmaceutical company
  • Applicants must provide the following:
  • Letter of Intent
  • Two recommendation letters (one from a supervisor and the second from a colleague)
  • Limited to 5 students or 5% of the final number of new attending students
  • Applicant must meet minimum student entry requirements to be considered for this preferred tuition fee (see above section)

To provide educational opportunities to self-paid students in a wide variety of countries with varying economic statuses, the Academy determines tuition fees based on several factors, including Sponsorship status (i.e. whether your tuition will be paid for by your company).

If you do not meet the above mentioned criteria the tuition is $9,600.

Group Pricing

<p>Companies interested in sponsoring employees to attend the Program should email IFAPP Academy at admissions@ifappacademy.org for information.</p>

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