Medical Writing in Pharmacovigilance. Update your English writing skills in this course - with many exercises!

Transcription

1 Medical Writing in Pharmacovigilance Update your English writing skills in this course - with many exercises!

2 FORUM Institut für Management GmbH Programme Overview of contents Key pharmacovigilance definitions Development safety update report (DSUR) Risk management plan (RMP) Periodic safety update report (PSUR)/periodic benefit-risk evaluation report (PBRER) English for regulatory documents Medical writing tips Practical exercises Introduction to pharmacovigilance Definition of key terms relevant for pharmacovigilance documents Pharmacovigilance documents in the life cycle of a medicinal product: scope and role DSUR - RMP - PSUR/PBRER Regulatory requirements Guidelines Contents Structure and template Role of the pharmacovigilance writer Interface with other functions; planning aspects Focus, overlap, timing of DSUR, RMP, and PSUR/PBRER Practical exercises English for regulatory documents Style and terminology Scientific, technical, and lay language Style insights How to enhance readability Common errors and practical exercises Questions, discussion and conclusions

3 FORUM Institut für Management GmbH Speaker: Dr Tiziana von Bruchhausen Personal Dates née Giordano Education 11/ /2000 Degree in Biology (focus on human physiopathology) University of studies of L Aquila, Italy 6/2002-6/2006 PhD in Cell and Molecular Biology, Open University of London, UK & San Raffele Sci. Inst., Milan, Italy 11/ /2011 Foundation Certificate in Medical Writing (Drug Development) EMWA EPDP 11/ /2012 Advanced Certificate in Medical Writing EMWA EPDP Professional data 9/ /2012 Drug safety officer and medical writer, Dr. Notghi Contract Research GmbH 1/ /2011 Group coordinator literature review and case processing; medical writer, Dr. Notghi Contract Research GmbH 1/ /2012 Group leader medical writing, Dr. Notghi Contract Research GmbH 10/ /2014 Freelance safety writer and medical writer, Safetywriting Present position Since 06/2014 Since May 2017 Senior global pharmacovigilance writer, Boehringer Ingelheim GmbH & Co. KG EMWA Vice President and Chair of the EMWA Pharmacovigilance Special Interest Group Interests/Experience - Pharmacovigilance regulatory writing (RMP, PSUR, DSUR, Addendum to Clinical Overview, patients narratives) - EU pharma package - Medical communication for the lay public (public summary of RMP, patient s brochures, web pages) - Literature review and summaries (including epidemiology of diseases and risks) - Medical writing for clinical studies (study protocols and reports, clinical summaries) - Case processing, case assessment, regulatory reporting

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5 FORUM Institut für Management GmbH Documentation Your speaker Dr. Tiziana von Bruchhausen 1

6 Medical Writing in PV Tiziana von Bruchhausen Senior Safety Writer Boehringer Ingelheim GmbH & Co. KG Workshop participants Who are you? Experience with pharmacovigilance (PV) and PV writing? Expectations from this workshop? Who am I? FORUM Dr. Tiziana von Bruchhausen Medical Writing in PV 2 2

7 3 Workshop goals Refresh/deepen some PV terms and concepts necessary for case narratives and PV writing Regulatory requirements, focus, structure, and contents of the main safety documents (case narratives, RMP, PSUR, DSUR) Where to find guidance and templates Common pitfalls and common errors Technical language and correct English Medical writing approach, skills and tricks FORUM Dr. Tiziana von Bruchhausen Medical Writing in PV Workshop outline Overview on the most relevant PV documents Medical Writing in PV Introduction to PV: key terms, medical concepts, case assessment Case narratives and company causality comment English for PV Development Safety Update Reports (DSUR) Risk Management Plans (RMP) Periodic Safety Update Reports (PSUR/PBRER) FORUM Dr. Tiziana von Bruchhausen Medical Writing in PV 4 3

8 Overview on the most relevant PV Documents FORUM Dr. Tiziana von Bruchhausen Medical Writing in PV 5 The Life-Cycle Approach (I) Understanding risk in the context of benefit Proactive PV Reactive PV Proactive approach: risk management to be prospective, dynamic and proportionate to risk FORUM Dr. Tiziana von Bruchhausen Medical Writing in PV 6 4

9 The Life-Cycle Approach (II) PV activities cover the entire life-cycle of a medicinal product Risks and benefits to be characterised in the pre- and post- POST- MARKETING DEVELOPMENT approval phase APPROVAL FORUM Dr. Tiziana von Bruchhausen Medical Writing in PV 7 PV at a Glance PV is the set of activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem (WHO, 2002*). Also applicable (with modified requirements) to herbals, traditional and complementary medicines, blood products, biologicals, medical devices, and vaccines. *Source: 8 FORUM Dr. Tiziana von Bruchhausen Medical Writing in PV 5

10 PV at a Glance (II) Monitoring of risks and benefits of a medicinal product -> Requirement for marketing authorisation holders 9 FORUM Dr. Tiziana von Bruchhausen Medical Writing in PV Pre-approval: Pre- and post-approval PV Limitation of detection of (rare, long-term) ADRs in clinical trials Post-marketing: Large patients exposure Experience in patient populations excluded from clinical trials PRE- APPROVAL POST- MARKETING Dr. Tiziana von Bruchhausen Medical Writing FORUM 10 in PV 6

11 Sources of safety information FORUM Clinical studies Spontaneous reporting Literature Observational studies Epidemiological studies Registries Patient supporting programmes Post-authorisation safety studies (PASS) Marketing studies 1 1 Dr. Tiziana von Bruchhausen Medical Writing in PV PV: Activities (1) AE/ADR REPORTING PERIODIC SAFETY REPORTS AE: adverse event ADR: adverse drug reaction SIGNAL EVALUATION SAFETY ANALYSES Risk characterisation and management FORUM Dr. Tiziana von Bruchhausen Medical Writing in PV 12 7

12 PV: Activities (2) Specific AE follow-up questionnaires PASS Additional monitoring Risk characterisation and management FORUM Dr. Tiziana von Bruchhausen Medical Writing in PV 13 Relevant PV Activities and Documents Preclinical studies Clinical studies Authorisation Post-marketing AE reporting DSUR RMP Case narratives (clinical trial reports; DSUR) CTD: Common Technical Document 1 4 CTD safety summary RMP/RMP updates Interim safety updates AE reporting Literature monitoring Signal detection PSUR RMP/RMP updates Case narratives Ad hoc safety reports PASS FORUM Dr. Tiziana von Bruchhausen Medical Writing in PV 8

13 PV aims and product life-cycle (I) Planning of measures to manage risks Characterisation of safety profile and risk management in the real-life setting Characterisation of safety profile (non-clinical and clinical data) Dr. Tiziana von Bruchhausen Medical Writing FORUM 15 in PV PV aims and product life-cycle (I) PSUR RMP updates RMP DSUR Important risks SAFETY PROFILE Important risks + missing information SAFETY PROFILE / RISK MANAGEMENT Important risks + missing information Benefits Interval vs cumulative RISK-BENEFIT ANALYSIS Dr. Tiziana von Bruchhausen Medical Writing FORUM 16 in PV 9

14 RMP, DSUR and PSUR (I) DSUR: periodic safety report in the preauthorisation phase PSUR: periodic safety report in the postauthorisation phase RMP: planning of PV activities and risk minimisation measures in the pre- and postauthorisation phase 1 7 FORUM Dr. Tiziana von Bruchhausen Medical Writing in PV DSUR, RMP and PSUR (II) DSUR focus SAFETY MONITORING Proactive assessment of risks and benefits RMP focus PLANNING Proactive risk characterisation and mimisation PSUR focus EVALUATION Ensure that risk-benefit balance remains favourable -> RMP, PSUR and DSUR may all be needed and may have Dr. Tiziana different von Bruchhausen 10 Medical Data Writing in Lock PV Points (DLP) FORUM Dr. Tiziana von Bruchhausen Medical Writing in PV 18 10