Certification in Pharmaceutical Medicine and Clinical Research The vision of regulators

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1 Certification in Pharmaceutical Medicine and Clinical Research The vision of regulators Presented by Sergio Bonini Professor of Medicine, Second University of Naples Expert-on-Secondment, European Medicine Agency PharmaTrain IFAPP SSFA Conference Rome June 11, 2015 An agency of the European Union

2 Disclaimer The views expressed in this presentation are the personal views of the speaker and may not be understood or quoted as being made on behalf of or reflecting the position of the EMA or one of its committees or working parties. European Medicines Agency, Reproduction is authorised provided the source is acknowledged. 2

3 Educational initiatives in Pharmaceutical Medicines Faculties of Pharmaceutical Medicine IFAPP IMI projects (IMI-TRAIN : EMTRAIN, PharmaTrain, Eu2P, SafeSci Met) Masters and Courses at Universities EMA and Network of National Drug Agencies 3

4 Innovation Personalized medicine Manufacturing and quality New licensing pathways New clinical trial designs EMA Hot Topics Clinical trials in neonates/ pediatrics Rare diseases Benefit/Risk assessment and patient preference Quantitative systems pharmacology Collaboration NCA-Academia relationship Clinical trial data sharing Patient registries Safe use of medicines, OTC Communication among stakeholders Training Training of regulatory science specialists Recruitment of experts Readiness for new technologies

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6 Topics to be covered and Professional Background Chemicals - Chemistry, Pharmacy Advanced therapies, biologics - Biology Devices - Physics, Engineering Disease management - MDs Clinical Trials - Methodologists Pharmacoeconomics - Economists Data collection and analysis - Informatics Legislation, intellectual pr. - Lawyers Ethical issues - Ethical Committees Governance - Managers Communication - Media experts

7 Regulatory Sciences Definition? 7

8 The role of regulatory science? Some definitions Guido Rasi (EU EMA) Regulatory science is defined as a range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision making throughout the lifecycle of a medicine. It encompasses basic and applied medicinal science and social sciences, and contributes to the development of regulatory standards and tools.

9 The role of regulatory science? Some definitions Margaret Hamburg (US FDA) We must also modernize our evaluation and approval processes to ensure that innovative products reach the patients who need them, when they need them. These new scientific tools, technologies, and approaches form the bridge to critical 21st century advances in public health. They form what we call regulatory science: the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.

10 The role of regulatory science? Some definitions Tatsuya Kondo (Japanese PMDA) Science of Estimation, specifically Regulatory Science estimates social impacts (benefit and risk) of scientific / technological progresses, and regulates and adjusts them for optimal social acceptance.

11 Current scenario: Post-licensing, treatment population grows rapidly; treatment experience does not contribute to evidence generation Courtesy of H-G Eichler

12 Adaptive licensing: after initial earlier license, number of treated patients grows more slowly, due to restrictions; patient experience is captured to contribute to real-world information Courtesy of H-G Eichler

13 The challenge ahead: omics and Big Data Massive amounts of data New kind of follow up, with new medical challenges Data will be available But does this fit into the existing health care products processes? Who is there to monitor & interpret this data? Are physicians ready to use data collected by their patient? (Modified from F. Ehman, EMA)

14 Who should deliver training, diplomas and certification Universities? The Network of Drug Agencies? Scientific Associations? Private institutions? Pharmaceutical Industry?. a joint network of all stakeholders involved up-to-now, not to disperse the excellent work done up-to-now 14

15 Which should be the target of educational programmes in Regulatory Sciences? Pre-graduate students? Post-graduate-students from different Faculties Diversified modules Core curriculum Academia, Health Care, Regulatory Institutions, Industry, CRO

16 Conclusions Entering the world of medicines requires a multidisciplinary background and specific educational curricula. The excellent initiatives developed in Europe represent the first step to create adequate competencies in this area. However, the increasing globalization calls for an enhanced harmonization of curricula and certifications. Regulatory Sciences represents an emerging discipline, still waiting for a consensus definition, which goes beyond the medical aspects of drug discovery, development, evaluation and marketing to include additional competencies needed to form future personnel for academia, heath care, industry and regulatory institutions.

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