Market Access for Pharmaceutical Products - Trends and Challenges

After the course, you will have strengthened your capacity to understand and deal with crucial market access issues. You will have learned about key trends in market access how market access decisions are made, and how the decision frameworks affect requirements for evidence for new health care interventions.

You will have:

• Acquired a basic market access vocabulary.
• Gained insight into the toolbox of the market access methodologies.
• Gotten an overview of the key challenges of market access.
• Identified the key stakeholders and their influence on the drug reimbursement and prescription process in some of the most important markets (e.g. US, UK, Germany and France)
• Gained an understanding of payers’ perspective of key markets and of new reimbursement models which are impacting market access.
• Developed skills that will allow you to understand the value of real world evidence.
• Integrated competencies on how to demonstrate product value.

This course will provide insight into the key principles and a practical understanding of Market Access as it relates to the pharmaceutical industry. The course starts with an overview of the key stakeholders and current trends in the global Market Access of pharmaceuticals followed by a review of hot topics, challenges and relevant issues through a combination of lectures, discussions, group work, and case studies.

The topics include:

• Introduction to Market Access – market trends, defining global market access for the 21st century, its importance for optimizing product launches and its implications for the entire organization.
• Patient centricity - the importance of understanding that the end-user must be the focal point of the entire process.
• Stakeholders - who they are, their perspectives, how and when to engage with 'payers'.
• Core concepts of Market Access – defining the concepts, theories and methods relevant for the pharmaceutical industry.
• Value generation – the role of clinical trials, real-world evidence, life-cycle management, and health economics.
• Health economic aspects of Market Access – economic and financial considerations, core concepts and vocabulary.
• Pricing and reimbursement – global vs. local optimization, reference-pricing systems in various markets.
• Trends in key markets
• Important decision-makers in selected countries.

The course is for professionals working in the field of pharmaceuticals. It is intended as continuing professional development for professionals in the pharmaceutical industry, particularly in regulatory affairs, medical affairs, legal functions, and sales and marketing, including decision-makers and administrators in the public and private sectors. The course offers an excellent introduction for those less familiar with Market Access and will provide a deeper understanding for those with experience of clinical drugs development or marketing.

Please note, however, that the course is not an advanced course for Market Access specialists.

The course is preapproved as an elective in the Master of Industrial Drug Development (MIND) programme and the Master of Medicines Regulatory Affairs (MRA) programme.

Participants must:

• Hold a relevant bachelor degree or equivalent
• Have a minimum of 2 years of relevant job experience
• Be proficient in English

This is a 5-day course.

• An optional examination is available (3 ECTS credits at Master’s level) in the form of an individual written assignment, based  a relevant set of questions provided by the course managers and based on an extended literature list.
• The course is preapproved as an elective in the MIND and MRA programmes at the University of Copenhagen.
• The exam is obligatory for Master’s students.

Dates for examination can be found in the exam schedule.

You may find relevant information about the exam in the course curriculum.