Efficient and Transparent Approval processes for Pharmaceuticals
The objective is for the participants to gain more knowledge on risk assessment, tools for benefit/risk assessment, and to develop their thinking on global pharmaceutical policy, stakeholders, market access of medicines and patient involvement. This will alter their behaviour with respect to how to ensure transparency in regulatory decision-making and how to evaluate quality of medicines.
The following topics will be addressed in the course:
- Global pharmaceutical policy focusing on historical reasons, ethics, differences, and useful international collaborations among stakeholders. Participants will learn to be aware and critical of stakeholders and their rationales for different requirements.
- Regulatory science focusing on selection and development of scientific tools, assessing quality of these tools, critical reflection on the impact of using different tools. The course covers how to evaluate the performance of drug regulations and regulatory instruments, the gaps of the tools and how to choose tools and methods that support regulatory decision-making.
- Risk assessment methods focusing on tools applied in different areas (safety, efficacy and quality), as well as discussion of cost vs benefit. The scientific approach enables course participants to challenge current concepts of benefit/risk assessment.
- Quality in the assessment process covers how to ensure assessors of sufficient competencies in the three basic areas and how to ensure a smoothly running process in the assessment phase plus the element on recognising other agencies’ assessments.
- Quality of the medicines marketed covers how to ensure that the pharmaceutical quality of the dossier is sufficient and how to ensure that the product delivered actually complies with what has been approved.
- Patient perspectives and involvement in drug development focusing on how to include patients and patient organizations during the approval phase of new treatments and introduction of new medicines.
- Access to medicines focusing on market access, price negotiations, availability of medicines, ethics, social disparity, and justice, intro to Health Technology Assessment (HTA). Within market access, key stakeholders will be identified and their respective role discussed. Cost containment vs benefits for patients and society will be examined as well as social justice and prioritization.
- Discussion on what is efficient and transparent approval of medicines, discussion of quality vs time, transparency and ethics. Dilemmas of transparency and trustworthiness are unavoidable when working in drug development. Understanding the different stakeholders’ perspectives and dilemmas, will provide course participants with tools and arguments to evaluate a regulatory dossier.
Participants must be related to the Danish Strategic Sector Cooperation (SSC) and are expected to have a post-graduate education and/or working experience within areas relevant to approval processes for pharmaceuticals. Participants must as a minimum have a bachelor degree in a relevant field and must have a good command of English.
This course is tailored for employees of centres for drug evaluation or similar, staff responsible for product and company approvals, specialists in clinical trials and those developing the framework/standards for assessing/approving drugs. The course does not aim for one particular employment category but depending on work responsibilities, both the experts and the decision makers will gain competencies.