Programme. Ethics in Regulatory Affairs for Pharmaceutical Products: dilemmas in decision-makings. Preliminary version ( )

Transcription

1 Location: MAERSK TOWER (Room OBS! 4 TH of October Room ) Programme Ethics in Regulatory Affairs for Pharmaceutical Products: dilemmas in decision-makings 3 rd 6 th October 2017 Preliminary version ( )

2 Tuesday the 3 rd of October Introduction, Setting the Scene and Pre-Human Studies with ethical focus Morning: Introduction, lectures and group work - SETTING THE SCENE: KEY CONCEPTS AND READY FOR HUMAN PHARMACOLOGY STUDIES 08:30-9:00 Welcome. Introduction to the course Presentation of the programme, the course leaders, the speakers and the participants (incl. expectations) Lourdes Cantarero, Assistant Professor, Faculty of Health and Medical Sciences, & Merete Schmiegelow, Honorary Industrial Ambassador in Regulatory Sciences, University of Copenhagen 09:00-10:00 Setting the scene An overview of the entire product development and life cycle with regulatory responsibilities in focus. Merete Schmiegelow 10:30-11:15 Group work Course case 1: stakeholders identification with ethics in focus Merete Schmiegelow 11:15-12:00 Unmet medical needs What-why-when: TPP, CCDS and PI 12:00 13:.00 Lunch Afternoon: Lectures, panel discussion and group work INITIATION OF HUMAN PHARMACOLOGY STUDIES 13:00-14:15 The regulator 14:15 15:15 The industry Ethical considerations impacting science, and science impacting ethical considerations in the transition into first-in-human (human pharmacology/phase 1) clinical trials including new, paediatric as well as orphan issues Ethical considerations and learning s to initiate and carry out first-in-human (human pharmacology/phase 1) clinical trials (a.o. CMC, non-clinical, target population and dose to select) Dr. Christian Schneider Head of the National Institute for Biological Standards and Control (NIBSC). Prior chair of the CHMP - Committee of Advanced Therapy (CAT) and the CHMP Biosimilar Medicinal Working Party both at the European Medicines Agency (EMA) Clinical - TBD Roche 15:15-15:45 Coffee Break 15:45 16:30 Panel discussion Including questions from the participants All speakers Moderator: TBD Danish Medicines Agency (DKMA) 16:30-17:15 Group work Course case 2: patients or healthy volunteers? Merete Schmiegelow and Vibeke Bjerregaard 18: Dinner

3 Wednesday 4 th of October Exploratory and Confirmatory studies with ethical focus Morning: Group presentation and lectures HUMAN EXPLORATORY AND CONFIRMATORY STUDIES 08:30-09:00 Group presentations Participants short presentations and Q&A from Day 1 Merete Schmiegelow and Lourdes Cantarero 09:00 09:30 Theories of ethics An introduction on theories of ethics in the biomedical field 09:30-10:00 National ethics committee 10:30 12:00 Regulator Learnings from ethical considerations in first-in-human, exploratory and confirmatory studies of new, paediatric and orphan drug issues, as appropriate Scientific ethical considerations and learning s from EMA and national scientific advice: ethical dilemmas for exploratory and confirmatory clinical trials Sofia K. Sporrong Associate professor, Faculty of Health and Medical Sciences, University of Copenhagen Prof. Karen Brøndum-Nielsen Chair of the Danish Committee on Health Research Ethics Sinan Badakci Sarac, Chief Medical Officer at the Danish Agency (DKMA), member of the EMA CHMP and several other CHMP working parties Afternoon: Lectures, panel discussion and group work HUMAN EXPLORATORY AND CONFIRMATORY STUDIES (CONTINUED) 13:00 13:45 Measuring patient aspects Patients related outcomes - What Why How When Lise Højbjerre, Principal Scientist, Novo Nordisk A/S 13:45-15:00 National regulator Example: Treatment burden Scientific ethical considerations and learning s from Clinical Trial Applications Elke Stahl Assessor, Federal Institute for Drugs and Medical Devices, BfArM, (Germany). Chair of the Clinical Trials Facilitation Groups (CTFG) 15:00-15:30 Coffee Break 15:30 16:30 The industry Ethical considerations and learning s from, exploratory and confirmatory clinical trials (Phase 2 and 3a) (a.o. CMC, Alice Troy, Regulatory Director, Biopharm Novo Nordisk A/S non-clinical, target population and dose to select) 16:30 17:15 Panel discussion Including questions from the participants All speakers Moderator: Lene Grejs Petersen Senior Adviser Clinical Trials, Danish Medicines Agency, DKMA 17:15 18:00 Group work Course case 3: Ethical dilemmas phase 2 and 3 Merete and Vibeke Bjerregaard

4 Thursday 5 th Products on the market Morning: Group presentations and lectures POST-AUTHORIZATION ACTIVITIES WITH ETHICAL FOCUS 08:30-09:00 Group presentations Participants short presentation and Q&A from Day 2 Merete Schmiegelow and Lourdes Cantarero 09:00-10:00 Cochrane Ethical issues in post-authorization drug trials Karsten Juhl Jørgensen, Deputy Director Nordic Cochrane Centre 10:30 12:00 Regulator Real-world evidence, pharmacovigilance risk assessment and benefit/risk monitoring and learning s Afternoon: Lectures, panel discussion and group work POST-AUTHORIZATION ACTIVITIES WITH ETHICAL FOCUS Doris Stenver Danish Medicines Agency (DKMA) Member of Pharmacovigilance and risk assessment Committee, EMA 13:00 13:45 The patient organisation Considerations and learnings Jan Geisler European Patients Academy (EUPATI) 13:45 14:30 The industry patient Considerations and learnings Lode Dewulf Consultant, prior UCB, Belgium 15:00 15:45 Panel discussion Including questions from the participants 14:30 15:00 Coffee Break All speakers Moderator: Merete Schmiegelow 15:45 16:30 Group work Course case 4: safety and benefit/risk Merete and Vibeke Bjerregaard

5 DATE THEME CONTENT TEACHER Friday 6 th The involvement of HTAs, Payers, Patients and Healthcare Professionals Morning: Group presentations and lectures HTAs and PAYERS 08:30-10:00 Group presentations Participants short presentations and Q&A from Day 4 and remaining Q&A from Day :30-12:00 EUnetHTA Why-who-what-when incl. ethical considerations, learnings, fees challenges and next steps, including collaborations with regulators and payers Merete Schmiegelow and Vibeke Bjerregaard Wim Goetsch Executive Board Chair, EUnetHTA Afternoon: Lecture, final evaluation and introduction to the exam PATIENTS AND HEALTHCARE PROFESSIONALS 13:00 13:45 Patients perspective Avoiding conflict of interest in stakeholder collaborations 13:45 14:30 HCPs perspective Avoiding conflict of interest in stakeholder collaborations Birthe Ryskov Chair of Rare Disease, Denmark (Danish Eurodis) Dr. Gonzalo Calvo, HCP representative, HCP Working Group, EMA 14:30 15:00 Coffee Break 15:00 15:30 Evaluation Final evaluation Merete Schmiegelow and Lourdes Cantarero 15:30-16:00 Exam Introduction to exam Merete Schmiegelow and Lourdes Cantarero Please note changes in the program can be expected