Expert Meeting: Agile meets regulations



Although agile methods have strikingly proven their benefits over classic project management methods far beyond IT-projects, they cannot be easily applied in every sector. In regulated business environments using these methods inevitably results in conflicts with common CSV procedures, as documentation according to classic waterfall models is still desired by inspectors. The actual question is no longer if we need agile methods but how to bridge the gap between two worlds.

This event will describe the current regulatory view on agile approaches and present possible solutions to close the gap. A vivid combination of presentations, discussions and networking will open up new perspectives to the participants and provide them insight into prior experiences of different companies in the pharma and medtech sector.

Keynote: “The Future belongs to Agile Organizations”, Prof. Dr. Ayelt Komus, University of Applied Sciences Koblenz

Target audience

Leaders and Specialists in the area of Software and/or Medical Device Development - Quality Assurance Managers, IT Planning & Strategy, Program and Project Management, Responsible persons for Project Methodologies and CSV, Heads of Project Portfolio Management and PSO


Unternehmen Mitte - Salon Belle Etage, Gerbergasse 30, CH-4001 Basel

Due to the interactive nature of the event and in order to allow targeted discussions the number of participants is limited to a maximum of 30.


CHF 195 / 180 €


15:00 h:

Get Started - Coffee and Welcome

15:15 h:

Keynote: The Future belongs to agile organizations

Prof. Dr. Ayelt Komus, University of Applied Sciences in Koblenz

• Agility is not a choice – it’s just the question how

• Why agility is a substantial way to increasing quality and compliance

• Benefits, spread and variety of agile methodologies

15:45 h:

Transition to an agile product development process for medical devices - an interim report

Dr. Nicolas Schwenck, Technology Platform Leader, PARI GmbH

• background: regulations and goals in the development process of inhalation devices

• The small "V" in the big "V": concepts and measures to use agile methods in the regulated environment

• First experiences: expected and unexpected challenges and wins

16:15 h:

Bridging the gap between Regulations and Agility

Christoph Piller, Business Unit Manager Life Science & Healthcare, msg industry advisors

• Short overview on regulations, including new MDR

• Conflict areas between agile methods and regulatory requirements

• Solution approaches, risk management

16:45 h:

Get Connected - Break with Networking and Collection of open Points & Questions

17:15 h:

The right combination is the key - Realizing the advantages of Scrum in a regulated project environment

Claus-Peter Koch, CEO, Heupel Consultants Schweiz

• Learn about specific hybrid and scaled solution approaches with integrated documentation and review needs

• Benefit from experiences and useful suggestions

17:45 h:

Open Panel Discussion – Agile meets Regulations: clash or synergy

• Find out about the different perspectives of Experts

• Bring in your questions and comments

18:30 h:

Get Connected – Apéro and Networking

with experts from different companies and the speakers


Event in cooperation with msg advisors. Download the flyer here.

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