PROGRAMME. The 22 nd Autumn Introductory Course: Target the Heart of European Regulatory Affairs. Intercity hotel, Berlin, Germany
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1 The 22 nd Autumn Introductory Course: Target the Heart of European Regulatory Affairs Intercity hotel, Berlin, Germany Monday 7 th Friday 11 th November 2016 PROGRAMME
2 Monday 7 th November Chair: Marion Kreitz, Bencard Allergie GmbH Marion Kreitz, Bencard Allergie GmbH 13:30 Arrival and Registration 14:00 Opening and introduction of day Marion Kreitz Bencard Allergie GmbH 14:05 Welcome and Opening Address Ronald de Meijer Astellas Pharma Europe B.V. Samantha Alsbury TOPRA 14:30 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 15:20 Development of Pharmaceutical Legislation The development of regulations, directives and guidelines Working parties Opportunities to influence legislation New legislation 16:15 Break 16:45 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 17:45 e-submissions Regulatory guidance leading to ectd Prerequisites for proper ectd usage Other e-submission initiatives including PIM EVMPD and IDMP E-submission readiness Marion Kreitz Bencard Allergie GmbH Birka Lehmann Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) Hans van Bruggen ectdconsultancy Hans van Bruggen ectdconsultancy 18:45 Case Study 1 Ice Breaker Marion Kreitz Bencard Allergie GmbH 19:30 Welcome drinks 20:00 Dinner
3 Tuesday 8 th November Chair: Feddo Hillen, Remedium Regulatory Affairs Feddo Hillen, Remedium Regulatory Affairs Quality Data and Non-clinical Data 08:30 Opening and introduction of day Feddo Hillen Remedium Regulatory Affairs 08:35 Chemical-Pharmaceutical data from a R&D Perspective Stefan Hirsch Importance of pharmaceutical development Novartis Pharma AG Clinical trial formulation Dosage forms and development Development: pitfalls and solutions Good Manufacturing Practice 09:35 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 10:35 Break 11:05 Biotech Products What are biotech products? Characteristics of product and production process How do they differentiate from other products? Biosimilars Sandrine Lemaire GlaxoSmithKline James Parsley GlaxoSmithKline 12:00 Lunch 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? Elizabeth Soames GlaxoSmithKline 14:00 Introduction to Case study 2 Feddo Hillen Case Study 2 Chemistry and Pharmacy Feddo Hillen Hans van Bruggen 16:45 Close of the day 19:30 Dinner in city (close to Branderburger Tor) Time slot opportunity for visiting Berlin highlights before dinner
4 Wednesday 9 th November Chair: Steve Harston, Consultant Anne Lenihan, Pfizer Ltd Clinical Data 08:30 Opening and introduction of day Steve Harston Consultant 08:35 Clinical (Efficacy) Data from a R&D perspective Lynda Troy Overview of clinical development AstraZeneca Phase I, II, III trials Setting up a study Regulatory strategy re clinical development including Health Technology Assessment Role of a Regulatory Professional 09:40 Clinical Trial Authorisations Ann Scott Clinical Trial Directive 2001/20/EC OA Regulatory Limited Initial application for authorisation of a clinical trial EU voluntary harmonised procedure Methodology studies 10:10 Break 10:45 Clinical Trial Authorisations, continued 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 14:00 Common Technical Document Module 5: Clinical (Efficacy) Data Clinical pharmacology data (PD & PK) Clinical efficacy and safety data Risk benefit analysis The link to the SPC 15:00 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 16:00 Break 16:30 Paediatrics Paediatric regulation Paediatric development Paediatric clinical trials Anne Lenihan Pfizer Ltd Anne Lenihan Ann Scott Lynda Troy AstraZeneca Ailise Carleton HPRA Jo Phipps AstraZeneca 17:30 Close of the day 18:00 Dinner
5 Chair: Thursday 10 th November Azzurra Ravizza, Pfizer Vicky Jones, Sapientia Regulatory Services Ltd. European Routes to Obtaining Marketing Authorisations 08:30 Opening and introduction of day Azzurra Ravizza Pfizer 08:35 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 09:20 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 10:30 The Role and Structure of EMA EMA, its role, responsibilities and structure EMA and relationships with national agencies Electronic links between the agencies Transparency 11:30 An Introduction to the Centralised Procedure: The practice An overview Interactions with the rapporteur and co-rapporteur 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 12:15 Lunch 13:15 Choice of Procedure and Introduction to Case study 4 Options available Points to consider when choosing the procedure Strategic considerations Kora Doorduyn-van der Stoep Medicines Evaluation Board in The Netherlands, Dutch member of the Co- ordination Group for MRP / DP (CMDh) Arthur Merlin Destreux TEVA EMA speaker to be confirmed Sabine Derey Glaxo SmithKline Vicky Jones 13:45 Case Study 4 Choice of Procedure Vicky Jones Katie Pye 15:45 Break 16:15 Scientific Advice and Interaction with Authorities The importance of seeking scientific advice When to seek advice 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 Kevin Hartley Assensus Consulting GmbH
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 18:30 Dinner Matthias Finkler Finkler GmbH
7 Chair: Friday 11 th November Steve Harston, Consultant Ronald de Meijer, Astellas Pharma Europe B.V. Maintenance of Marketing Authorisations 08:30 Opening and introduction of day Steve Harston Consultant 08:35 Variations and Renewals Ronald de Meijer Variation Regulation Astellas Pharma Europe Categorization (Type IA, IA(in), IB, II) B.V. New application vs variation Grouping and worksharing New legislation on renewals Requirements and documents to be provided Timelines for submission and assessment 09:30 Life cycle Management Life cycle management why? Life of your product Extending the life of your product Regulatory strategies Hot topic shortage of medicinal product ` Introduction to Case Study 5 Case Study 5 Variations Nb participants to take drinks to the break-out rooms 12:30 Lunch The Registration of Medical Devices Key differences with Pharmaceuticals What is Europe (EU, EC & EEA)? Key Players: Roles & Responsibilities Directives Availability of devices National issues The future 14:30 Pharmacovigilance and Risk Management Legal requirements new PhVig legislation Definitions and conventions Good drug safety labelling practice Regulatory action with regards to drug safety Electronic submissions Safety Risk Management and why Risk Management regulatory status, programmes, examples and its value Andrew Willis A. Willis Consulting Ronald de Meijer Matthias Finkler Jonathan Hughes JHRA Ltd. Speaker to be confirmed 15:30 Chairperson s Closing Remarks Steve Harston 15:45 End of course
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