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| MedDRA is an international standard medical terminology for use in the pharmaceutical / biological / devices industry for purposes of recording, analysing and reporting medical information about patients, including adverse events, therapeutic indications for products, laboratory and clinical investigations, and medical and social history. It is widely used throughout the world, including use by the US, EU and Japanese regulatory authorities and is mandatory for reporting suspected adverse reactions by companies in the EU and Japan. The terminology is very large and complex and, as a result, there are significant possibilities for error in both recording and analysing safety data from clinical trials and from marketed products. This highly interactive and entertaining course, from a leading world expert on the subject, provides an opportunity to come to grips with this essential component of clinical trial and marketed product safety. |
| Benefits to the Participants |
- Gain a clear understanding of the MedDRA medical terminology, its structure and purpose
- Learn “hands on” how to code using MedDRA, but also how to search safety databases for medical conditions
- Understand the implications of using MedDRA for identifying safety concerns in clinical trials and post-marketing
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| Issues to be covered |
Day 1
- Background: development of MedDRA, regulatory status
- Structure and scope of MedDRA
- The maintenance organisation
- Hands on coding examples and exercises using a browser
- Guidelines in selecting MedDRA terms
- Version control
- Course test
Day 2
- Revision
- Pitfalls in searching safety databases using MedDRA
- Standardised MedDRA Queries
- Looking for safety signals with MedDRA
- Implications of using MedDRA for clinical trial safety data
- Guidelines for data retrieval and presentation
- MedDRA and labelling
- Course test
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| Who should attend |
- Individuals involved in coding safety data
- Data management staff
- Anyone working in pharmacovigilance / clinical trial safety
- Physicians and others involved in the analysis or review of clinical trial or post-marketing safety data
- Those involved in the preparation or review of periodic safety update reports or annual safety reports, risk management plans
- Quality personnel – CQC, auditors
- Investigators – PIs, sub-investigators, clinical staff members
- Members of the Helsinki Committees / Etics commitees
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| About the Speaker |
Dr Elliot Brown MB ChB BMedSci DipPharmMed MRCGP FFPM FRCP(Ed)
Elliot Brown is widely known as an expert in pharmacovigilance. After working as a family doctor he spent 10 years in senior positions in various companies and was a Senior Medical Assessor for 5 years at the UK MHRA. He was UK representative on the EMA’s Pharmacovigilance Working Party, a member of the ICH M1 Expert Working Group that developed MedDRA and a founding member of the CIOMS working group on Standardised MedDRA Queries. He has carried out training on MedDRA for pharmaceutical companies and regulatory agencies for many years.
He was on the WHO Uppsala Monitoring Centre signal review panel and is currently a member of an EU-funded international research consortium into improving the monitoring of safety of medicines led by WHO and is a member of the Executive Committee of the International Society of Pharmacovigilance.
Elliot is a member of the Editorial Boards of the journals Drug Safety, Pharmacovigilance Review and Pharmaceutical Medicine. He has published extensively on pharmacovigilance and on MedDRA as well as chairing and speaking at numerous international conferences.
For the last 11 years, Elliot has been Managing Director of Elliot Brown Consulting Ltd. He is also a founding director of PrimeVigilance Ltd, a company offering global pharmacovigilance services. |
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