The 23 rd Autumn Introductory Course:

Transcription

1 The 23 rd Autumn Introductory Course: Target the Heart of European Regulatory Affairs Prague, Czech Republic Sheraton Prague Charles Square hotel Zitna 561/8, Prague November 2017

2 Monday 13 November (Day 1) Chair: Marion Kreitz, Bencard Allergie GmbH 13:30 Arrival and Registration 14:00 Opening and introduction of day 14:05 Welcome and Opening Address 14:30 15:20 16:15 Break :45 How does Regulatory Affairs fit into the Picture? The importance of Regulatory Affairs Where does Regulatory Affairs fit into the normal structure of a pharmaceutical company The role of a Regulatory Affairs Professional A future in Regulatory Affairs Current hot topic transparency Future of the Pharmaceutical Industry Development of Pharmaceutical Legislation The development of regulations, directives and guidelines Working parties Opportunities to influence legislation New legislation Common Technical Document Module 1: Administrative Information & Prescribing Information Introduction to CTD Overview of Module 1 Type of application (including abridged applications) Summary of Product Characteristics (SmPC) Application form including appendices PIL user testing EU regional requirements e-submissions Regulatory guidance leading to ectd Prerequisites for proper ectd usage Other e-submission initiatives including PIM EVMPD and IDMP E-submission readiness 18:45 Case Study 1 Ice Breaker 19:30 Welcome drinks 20:00 Dinner Marion Kreitz Bencard Allergie GmbH Ronald de Meijer Astellas Pharma Europe B.V. Andrew Thornley TOPRA Birka Lehmann Formerly working for Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) ectdconsultancy ectdconsultancy Marion Kreitz Bencard Allergie GmbH

3 Tuesday 14 November (Day 2) Quality Data and Non-clinical Data Chair:, ectd consultancy 08:30 Opening and introduction of day 08:35 09:35 10:35 Break Chemical-Pharmaceutical data from a R&D Perspective Importance of pharmaceutical development Clinical trial formulation Dosage forms and development Development: pitfalls and solutions Good Manufacturing Practice Common Technical Document Module 3: Quality data from a dossier perspective Build up of Module 3 Drug Master File and its implications Drug Product: Excipients and their choice Stability requirements Quality Overall Summary: a dossier entrance ectd consultancy Stefan Hirsch Novartis Pharma AG Sandrine Lemaire GlaxoSmithKline 11:05 Introduction to Case study 2 11:15 Case study 2 Chemistry and Pharmacy 13:00 Lunch 14:00 Feedback session Case study 2 14:45 Biotech Products What are biotech products? Characteristics of product and production process How do they differentiate from other products? Biosimilars 15:45 Break What do you need to know as a Regulatory Person about Preclinical? Value of regulatory First necessary first trial of man Further preclinical data for the MAA Environmental risk assessment? 17:15 Close of the day Dinner in city Sandrine Lemaire Sandrine Lemaire Tejash Shah GlaxoSmithKline Elizabeth Soames GlaxoSmithKline

4 Wednesday 15 November (Day 3) Clinical Data Chair: Steve Harston, Consultant 08:30 Opening and introduction of day Clinical (Efficacy) Data from a R&D perspective Overview of clinical development Phase I, II, III trials 08:35 Setting up a study Regulatory strategy re clinical development including Health Technology Assessment Role of a Regulatory Professional Clinical Trial Authorisations Clinical Trial Directive 2001/20/EC 09:40 Initial application for authorisation of a clinical trial EU voluntary harmonised procedure Methodology studies 10:10 Break Clinical Trial Authorisations, continued 10:45 Substantial/Non-substantial amendments End of trial notification Pharmacovigilance for Investigational Medicinal Products 11:00 Introduction to Case Study 3 Case Study 3 Clinical Trial Case Study 13:00 Lunch Common Technical Document Module 5: Clinical (Efficacy) Data Clinical pharmacology data (PD & PK) 14:00 Clinical efficacy and safety data Risk benefit analysis The link to the SPC 15:00 16:00 Break 16:30 Common Technical Document Module 2: Overviews and Overall Summaries Structure and purpose of Module 2 Content and presentation of quality, non-clinical and clinical overviews and summaries Consistency and links between documents Paediatrics Paediatric regulation Paediatric development Paediatric clinical trials 17:30 Close of the day 18:00 Dinner Steve Harston Consultant Lynda Troy AstraZeneca Ann Scott OA Regulatory Limited Anne Lenihan Pfizer Ltd Anne Lenihan Ann Scott Lynda Troy AstraZeneca Geraldine O Dea Health Products Regulatory Authority Jo Phipps AstraZeneca

5 Thursday 16 November (Day 4) European Routes to Obtaining Marketing Authorisations Chair: Azzurra Ravizza, Pfizer Ltd 08:30 08:35 09:20 Opening and introduction of day The Mutual Recognition Procedure & the Decentralised Procedure: the theory A short overview Overview of MR and DC procedures CMDh referral process Duplicate licenses Impact of prescription status The Mutual Recognition Procedure & the Decentralised Procedure: the practice Eligibility for MRP or DCP MRP first and repeat use DCP overall timings and critical timepoints Choice of Reference Member State Validation and the Clock-stop Phase Responding to questions Post-procedure activities 10:00 Break The Role and Structure of EMA EMA, its role, responsibilities and structure 10:30 EMA and relationships with national agencies Electronic links between agencies Transparency An Introduction to the Centralised Procedure: The practice An overview Interactions with the rapporteur and co-rapporteur 11:15 How to manage the procedure: internally and externally Practical experience to date including orphan drugs Implications of using the procedure public assessment reports & binding decisions Accelerated pathways 12:15 Lunch Choice of Procedure and Introduction to Case study 4 Options available 13:15 Points to consider when choosing the procedure Strategic considerations 14:00 Case Study 4 Choice of Procedure 15:30 Break Scientific Advice and Interaction with Authorities The importance of seeking scientific advice When to seek advice 16:00 EMA vs. national advice: differences and how do we decide which route to take Practical advice for interactions with agencies Interactions with PRAC Health Technology Assessment interaction Oral hearing Azzurra Ravizza Pfizer Ltd Kora Doorduyn-van der Stoep Medicines Evaluation Board in The Netherlands Arthur Merlin d Estreux TEVA Agnes Saint Raymond EMA Azzurra Ravizza Pfizer Ltd Vicky Jones Sapientia Regulatory Services Ltd Vicky Jones Azzurra Ravizza Claire Onody UCB

6 17:00 Abridged Applications and Generics Legal routes of abridged applications Data exclusivity Patents Specifics of generic products 18:00 Close of the day 19:00 Dinner Matthias Finkler Finkler GmbH

7 08:30 08:35 Opening and introduction of day Friday 17 November (Day 5) Maintenance of Marketing Authorisations Chair: Steve Harston, Consultant Variations and Renewals Variation Regulation Categorization (Type IA, IA(in), IB, II) New application vs variation Grouping and worksharing New legislation on renewals Requirements and documents to be provided Timelines for submission and assessment Steve Harston Consultant Ronald de Meijer Astellas Pharma Europe B.V. 09:30 10:15 Lifecycle Management Life cycle management why? Life of your product Extending the life of your product Regulatory strategies Hot topic shortage of medicinal product Commercial strategies Introduction to Case Study 5 Case Study 5 Variations 12:30 Lunch The Registration of Medical Devices Key differences with Pharmaceuticals What is Europe (EU, EC & EEA)? Key Players: Roles & Responsibilities 13:30 Directives Availability of devices National issues The future Pharmacovigilance and Risk Management Legal requirements new PhVig legislation Definitions and conventions Good drug safety labelling practice 14:30 Regulatory action with regards to drug safety Electronic submissions Safety Risk Management and why Risk Management regulatory status, programmes, examples and its value; educational materials 15:30 Chairperson s Closing Remarks 15:45 End of course Andrew Willis A. Willis Consulting Ronald de Meijer Matthias Finkler Louise Olliver RQ2 Limited Pauline Gerritsen Gerritsen Pharmacovigilance Consulting Steve Harston