CERTIFICATION PROGRAM

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.

GMDP 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.

GMDP 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 with 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 November 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.
Click here to view the Student Academic Calendar (link opens in new window)

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 Project (EPP) with essays

Program Modules

Module 1: Fundamentals of Medicines Development
Understand Medical Affairs in the pharmaceutical lifecycle.

Topics: Clinical pharmacology, health economics, clinical development, regulations, long-term safety, patient roles.

Module 2: Medical Affairs and Health Economics
Learn Medical Affairs’ role in patient access.

Topics: Evidence generation, health economics, commercialization, digital technologies, regulatory approval.

Module 3: Drug Discovery, Exploratory and Confirmatory Development
Study drug discovery and trials.

Topics: Biopharmaceutical formulation, safety evaluation, human trials, statistical evaluation, evidence-based medicine.

Module 4: Clinical Trials: From Concept to Clinical Study Report
Conduct quality clinical trials.

Topics: Ethics, subject protections, quality management, data collection, budgeting, trial failures, decentralized trials.

Module 5: Regulatory Affairs, Drug Safety and Pharmacovigilance
Explore regulatory frameworks.

Topics: US, EU, emerging economies, global harmonization (ICH), regulatory procedures, risk management, safety reporting.

Module 6: Medical Affairs as a Strategic Business Partner
Evolving role of Medical Affairs professionals.

Topics: Ethics, teamwork, patient roles, organizational performance, medical education, quality management, strategic alliances, research review.

PROGRAM TUITION

The total tuition for our program is $9,800.

Flexible payment plans and financial assistance are available. Tuitions range from $4,900 to $9,800.

See special pricing

GMDP 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)

Is there financial assistance or special pricing?

Yes, GMDP Academy offers financial assistance and special pricing, including full and partial scholarships, to ensure accessibility for students worldwide. We provide the following pricing groups:

King’s College London Invitees
- Tuition fee: $9,000
- Applicants must provide the following: referral from King’s College London
Regulatory/Government Agency Employees
- Tuition fee: $4,900
- Limited to 5% (including the financial support applicants) of final cohort
- A personal letter of intent
- A letter of recommendation from a supervisor that includes verification of the applicant’s employment.
National Associations of Medicines Development:

Members of a national medicines development association interested in partnership opportunities, including special pricing consideration and potential revenue-sharing, should contact us at admissions@gmdpacademy.org
Self-Paid Students
- Tuition: $0 – $9,800
- Flexible payment plans are available.
- The Academy offers scholarships to self-paid students to provide educational opportunities in various countries with differing economic statuses. Up to two full scholarships may be awarded to exceptionally well-qualified applicants.
- Applicants interested in applying for a scholarship will find this option available within the application form. The application includes dynamic fields that adjust based on individual responses. Those who indicate they are self-paid students will have the opportunity to apply for a scholarship.

Scholarship Application Requirements:

- Applicants must not be employed by a pharmaceutical company upon submission of their application.
- Applicants must be self-funded.
- Submission of a personal letter of intent.
- Submission of a letter of recommendation from a current or former supervisor or an academic advisor, preferably from individuals or organizations involved in medicines development or related disciplines.

Scholarship Determination Criteria:

The GMDP Academy Admissions Board determines scholarship eligibility based on several factors, including:

- Country of Residence
- Employment Status
- Employer
- Application Documents

Partial Scholarships

Partial scholarships are limited to 5% of the final cohort at the Academy’s discretion. This includes applicants from regulatory or government agencies.

Full Scholarships

We honor the legacies of pioneers in pharmaceutical medicine through two fully paid scholarships that may be awarded each academic year to highly-qualified candidates:

- The Herman Lahon Scholarship:

Named after Dr. Herman Lahon, a pioneer in pharmaceutical medicine and the founding President of IFAPP. Dr. Lahon, along with the other IFAPP founders, conceived the idea of holding an international meeting of Medical Advisers (as pharmaceutical physicians were then known), that would bring together physicians and scientists from the pharmaceutical industry with those working in research institutes and academic medicine. Their objective was to internationalize the advancement of knowledge of therapeutic agents and their actions, and also to foster the relationship between industry and academia. This scholarship supports young pharmaceutical physicians and drug development scientists from emerging regions.

- The Fritz Bühler Scholarship:

Named in honor of Professor Dr. Fritz R. Bühler, a renowned cardiologist and founder of the European Center for Pharmaceutical Medicine (ECPM). Dr. Bühler was instrumental in developing and harmonizing educational programs in pharmaceutical medicine across Europe and globally, when he acted as the first President of PharmaTrain, a European Union “Innovative Medicines Initiative (IMI)” funded project aimed at the harmonization of educational programs in Medicines Development. This fellowship supports the education and promotion of young experts in pharmaceutical medicine.

Ready to take the next step? Apply now and unlock your potential!

Questions?

Fill out the form below to receive more information, or contact us directly.

Office headquarters

GMDP Academy Inc.
420 Lexington Avenue. Suite 300
New York, NY 10170

Phone number

+1-332-333-2438

Email

admissions@gmdpacademy.org

GMDP Academy is a registered 501(c)3 non-profit charitable organization based in the United States.