|By PR Newswire||
|March 13, 2014 07:00 PM EDT||
DUBLIN, March 13, 2014 /PRNewswire/ --
Research and Markets (http://www.researchandmarkets.com/research/drlfwg/new_eu) have announced the addition of the "New EU Pharmacovigilance Legislation - The Complete Picture (Course, London)" conference to their offering.
(Logo: http://photos.prnewswire.com/prnh/20130307/600769 )
The New EU Pharmacovigilance Legislation - The Complete Picture Course will be held on the 24th & 25th March 2014 at the Rembrandt Hotel, London
The 15 modules concerning Pharmacovigilance are a major departure in terms of the Pharmacovigilance conducted over the last 5 years in Europe since the introduction of Vol IXa. The intention of the course is to look at these modules and their requirements, examine how they overlap and fit together and what Companies need to do in terms of their legal requirements; training; changes and introduction of SOPs; and the links to other Departments - not just Pharmacovigilance.
WHO SHOULD ATTEND
This course will be of particular benefit to anyone working in Pharmacovigilance, including EU QPs / Deputies of Pharmacovigilance, as well as Quality Assurance; Compliance & Auditing and Regulatory personnel. It will also be of interest to anyone requiring an overview of this important new legislation.
Key Topics Covered:
DAY ONE - 24 March 2014
09.30 - Introduction & Welcome
The Legislation Outline for 1235/2010 & 2010/84
- Impact on previous legislation
- Enforcement of new legislation
- Purpose of the new legislation and its focus
- National variations
10.15 -The Impact on ICSR Safety Reporting in Europe
- Changes to expedited reporting
- Compliance monitoring
- Regulatory Quality Assessments - what and why
- The EU Product Dictionary Database - XEVMPD
- Electronic versus paper reporting - immediate changes and proposed
11.15 - Coffee
11.40 - The Impact on ICSR Safety Reporting in Europe...continued
12.15 - (a) PSURs/PBRERs
- Changes for EU PSUR submissions
- Revision of PSUR timelines
- Changes in the format of the PSUR - ICH E2C (R2)
- EU PSURs v rest of world
- The PSUR and Risk Management Plans
13.00 - Lunch
14.00 - (b) DSURs
- ICH E2F - The DSUR
- Content of the DSUR
- The DSUR and the PSUR/PBRER
- The IBD
15.15 - Tea
15.35 - The PV Master File
- The DDPS - What happens now
- Transition from DDPS to PV Master File
- The PV Master File - Purpose and Maintenance
17.00 - End of Day One
DAY TWO - 25 March 2014
09.00 - The New Legislation and Quality Management (QM)
- QC, QA and QM
- The purpose of QM
- Requirements of QM and examples of QM activities
- The responsibilities of the licence holder and QM
10.30 - Products with Additional Monitoring & Safety Communication
- ADR reporting and labelling
- RMPs and Labelling
- Medical information and RMPs
- Internal and external communication of new product safety issues
11.15 - Coffee
11.35 - Signal Detection Activities
- The EMA and Signal Detection
- Requirements from the MAH and Signal Detection
- Signal Detection and the internet
- Signal Detection and RMPs
12.30 - Lunch
13.30 - Pharmacovigilance Audits
- Format of the audit
- Risk based approach to audits
- Audit findings and Corrective Actions (CAPA)
- Audits and the Pharmacovigilance Master File
14.30 - Tea
14.45 - Risk Based Inspections
- The Inspection format
- The Inspection risk assessment
- Inspection scope
- Inspection findings
- Regulatory actions
16.30 - Close of Meeting
Graeme Ladds, Director of PharSafer, has over 20 year's experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. The last ten years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for large multi-national and national companies, and helping with regulatory inspections.
For more information visit http://www.researchandmarkets.com/research/drlfwg/new_e
Media Contact: Laura Wood, +353-1-481-1716, [email protected]
SOURCE Research and Markets
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