Michael Berntgen
Amsterdam, NH, Netherlands
Last Updated: 09/26/2026
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Found 14 publications
Multistakeholder scientific advice for medicinal products used in combination with a medical device or a companion diagnostic in the EU-summary of a Focus group discussion.
Journal: Frontiers in medicine
Published: March 14, 2025
Challenges and ongoing initiatives towards better integrated EU scientific advice.
Journal: Frontiers in medicine
Published: July 30, 2024
Medicines for an aging population: The EMA perspective and policies.
Journal: Journal of the American Geriatrics Society
Published: January 04, 2024
Navigating the path towards successful implementation of the EU HTA Regulation: key takeaways from the 2023 Spring Convention of the European Access Academy.
Journal: Health research policy and systems
Published: October 29, 2023
An Inclusive Civil Society Dialogue for Successful Implementation of the EU HTA Regulation: Call to Action to Ensure Appropriate Involvement of Stakeholders and Collaborators.
Journal: Journal of market access & health policy
Published: October 11, 2023
Inclusion of functional measures and frailty in the development and evaluation of medicines for older adults.
Journal: The lancet. Healthy longevity
Published: July 28, 2023
The role of stakeholder involvement in the evolving EU HTA process: Insights generated through the European Access Academy's multi-stakeholder pre-convention questionnaire.
Journal: Journal of market access & health policy
Published: June 07, 2023
Paediatric Strategy Forum for medicinal product development of chimeric antigen receptor T-cells in children and adolescents with cancer: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Journal: European journal of cancer (Oxford, England : 1990)
Published: September 28, 2021
Strengthening the Interface of Evidence-Based Decision Making Across European Regulators and Health Technology Assessment Bodies.
Journal: Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
Published: August 02, 2021
Digital technologies for medicines: shaping a framework for success.
Journal: Nature reviews. Drug discovery
Published: May 14, 2020
Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines.
Journal: British journal of clinical pharmacology
Published: September 30, 2019
Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines.
Journal: Clinical pharmacology and therapeutics
Published: October 09, 2017
Last Updated: 09/26/2026