Why CAS ETH in Regulatory Thinking?

How to become a better Regulatory Affairs Specialist!

In pharma, medicine and the medtech industry, human beings play the central role. Even if one rightfully thinks of the patient first and the attending physician second in this context, these groups of humans (stakeholders) do not yet represent all interest groups that have a legitimate concern and requirements for healthcare products (drug, in vitro a medical device or software as a medical device). In general, we can identify and define five stakeholder groups, each of them compiled of and represented by various human beings, with different needs:

• The Patient
• The Physician / Healthcare Professional
• The Administration / Purchasing Hospital
• The Regulatory authority / Notified Body
• The Healthcare Agencies / Insurances

Depending on their interest, different stakeholders have different requirements for the healthcare product.

• The patient wants the product to improve her/his state of health.
• The physician wants the product to be safe and easy to use.
• The hospital purchaser wants to buy the product “cost-efficient” and simply be reimbursed.
• Regulatory authorities want all approval documents for the product or service to be available, transparent, complete and conclusive.
• Finally, the insurance companies want to relieve public and private coffers with a positive supply effect.

This course is aimed at (non-)experts in the healthcare business who want to learn why it is important to know about design and development processes, validation instruments, alternatives in clinical trials and different certification and reimbursement strategies. The course gives insight in the various disciplines in regulatory affairs activities and compiles these in a unique approach, defined as “Regulatory Thinking”.

The Regulatory Thinking perspective 

“Regulatory Thinking” looks at a business idea, a research project, an existing technology or product from different perspectives: From the perspective of the developer, the patient, the user, the payer and the regulatory authority. Only if all the different perspectives are known and understood in general a business idea can be turned into a safe and highly effective medical or medicinal product or technology that can establish itself on the market. The participants will learn in this 10 month course interactively through (their own) use cases

• how to turn regulatory requirements into business opportunities,
• how to document, analyse and validate design and development in an effective but compliant way,
• how to stay on top of things in the jungle of regulatory requirements.

The course will go through the full process creating awareness for every detail from the very first idea to post market evaluation of a drug, medical device or software as a medical device.

The participant will not become an expert on each topic, but a generalist that is highly needed in the healthcare sector: Whether you are a business leader looking to drive a business forward, a government employee looking to ensure the safety of healthcare products, a payer looking to reimburse healthcare expenses, or defining new reimbursement paths.

Take advantage from ETH

ETH is one of the world's best universities and the best university in continental Europe (Times Higher Education ranking). ETH has a longstanding history in developing novel technology. Recently it added a significant pool of regulatory expertise. The combination of both will help to transform your ideas into products.

A lifetime connection with ETH

After having graduated with a Certificate of Advanced Studies (CAS) from ETH you can join the ETH Alumni Association. Stay connected and become inspired! As an ETH alumnus, you will also enjoy various member benefits.