Workshops
Pre conference workshop - preparing for a pharmacovigilance inspection
Tuesday 16 September 2008
This workshop will examine requirements for pharmacovigilance inspections, from preparation, during the inspection and how to follow up
Agenda
- Preparation for a pharmacovigilance inspection
- Inspection types, GCP, PV inspections
- Expectations for the inspector and the pharmaceutical company
- Legal basis for inspections – highlighting current legislation
- What are inspectors looking for on a macro and micro level?
- How to respond to feedback – where to make improvements
- What documentation needs to be in place?
- Examples of documentation, best practice for submission
- Challenges in the process
- What level of involvement will your team have? Identifying different roles and their place in the inspection process
The workshop will begin at 09:00 and will end at 17:00. Lunch and refreshments will be provided. For further information on the agenda and course leader visit the website.
About your workshop leader
Symogen Ltd, based in Marlow, UK was founded in January 2007, deals with all aspects of pharmacovigilance activities including high end services in this field with back up support from India office at a very cost effective price for the pharmaceutical industry. Symogen consists of highly qualified and experienced pharmacovigilance physicians, scientists, regulatory affairs personnel and IT specialists with long standing experience in pharmaceutical industry, academic pharmacovigilance and regulatory agency in Europe, USA and India.
Symogen Pharmacovigilance services
- End to end Case management for clinical trials and marketed products. AE reporting, collection and follow up. Literature Searches.
- Medical Evaluation/MedDRA Coding/Single Case Assessments
- Provision of European Qualified Person Services
- ASR/PSUR/PADER preparation and review
- Signal Detection and Data Mining
- Development of Pharmacovigilance Specifications and RMPs/REMS
- Pharmacovigilance Audits and Inspections
- Pharmacovigilance Training & Education
- Medical Writing
Symogen already runs a highly successful Certificate Course in Pharmacovigilance and Pharmacoepidemiology in India which is taught by an International Faculty. This course has been awarded 90 CME/CPD Credits by the Faculty of Pharmaceutical Medicine, The Royal College of Physicians, London, UK. Two batches of this course has already been completed.
www.symogen.net
Post conference workshop - QP in pharmacovigilance: a practical approach
Friday 19 September 2008
This practical, interactive and problem solving session will look at the key roles and responsibilities of the QP in pharmacovigilence. It will address the key challenges that are associated with this role as well as highlighting the impact of regulatory changes and all legal implications.
Agenda
- Legal implications for the QP
- Curriculum – is there a need for a standardised system?
- How the role has changed with the implementation of Volume 9a?
- Limitations to the role
- How company structure can support the role of the QPPV
- Contract QPPVs
The workshop will begin at 09:00 and will end at 17:00. Lunch and refreshments will be provided. For further information on the agenda and course leader visit the website; www.healthnetworkcommunications.com.
About your workshop leaders
SPM² (safety projects & more GmbH) provides state of the art pharmacovigilance services for the pharmaceutical industry. SPM² was founded in 2005 by physicians, IT-specialists and business executives with long standing experience in the pharmaceutical industry in Europe and the USA.
Pharmacovigilance services:
- Planning and implementation of EU compliant pharmacovigilance system
- Development of pharmacovigilance specification and risk management plans
- Crisis Management Planning and SOP development
- Qualified Person Pharmacovigilance Europe
- E2B compliant drug safety database
- Generation of PSURs
- Single Case Management pre- and post approval (SUSAR and ICSR)
- Remote data entry in client’s safety databases
- Pharmacovigilance audits
- Literature Research
- Training
To register for the pre conference workshop or to make an enquiry call +44 (0) 207 608 7055, email customerservices@healthnetworkcommunications.com or visit www.healthnetworkcommunicationscom.
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