Health Canada - Drug and Medical Device Recall Listings - (December 28, 2011): This section has been designed to... http://t.co/P2jIZ304
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The EMA has released the seven draft PV guidance modules released today covers major process in the safety monitoring of medicines.
• Module I: Pharmacovigilance systems and their quality systems;
• Module II: Pharmacovigilance systems master files;
• Module V: Risk management systems;
• Module VI: Management and reporting of adverse reactions to medicinal products;
• Module VII: Periodic safety update reports;
• Module VIII: Post-authorisation safety studies;
• Module IX: Signal management.
The Agency is seeking comments on the practical implementation of the legislation as outlined in these modules. The underlying legal requirements cannot be altered through this consultation process.
The Agency intends to finalise and publish these modules by July 2012, after comments from stakeholders have been taken into account.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000345.jsp&mid=
14 hours ago
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The first seven GVP Modules will be launched tomorrow and comments will have to be received before 18 April 2012.
They will include
Definitions_+
ICSR
PASS
PhV Quality System
PV masterfile
PSUR
RMP
Signal detection
1 day ago
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The European Commission has published transitional arrangements for the new pharmacovigilance legislation in preparation for the coming into force of the legislation in July 2012. Of particular interest to marketing-authorisation applicants and holders, the document provides answers to both legal and practical questions on a range of topics including renewal of applications, pharmacovigilance system master files and risk management plans.
http://ec.europa.eu/health/files/pharmacovigilance/2012_02_qa_phv.pdf
1 day ago
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The implementation of (Regulation (EU) No 1235/2010 and Directive 2010/84/EU) only a few months away. The European Commission have issued a Q&A document which addresses questions that have been raised to the Commission as regards the correct phasing-in of the new requirements and the specific dates from which the new rules apply. It is intended to facilitate the preparatory work of all stakeholders involved.
Have a look here: http://ec.europa.eu/health/files/pharmacovigilance/2012_02_qa_phv.pdf
2 days ago
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The revision of the draft proposal for new directive for clinical trials in Europe is now expected to be released around October 2012
5 days ago
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The PV guidance documents in the first wave is probably going to be delayed until 24 Feb and there will be an 8 week commenting period
5 days ago
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The European Medicines Agency and CHPM has approved a Dear Healthcare Provider letter warning about risk for giving wrong dose due to confusion about strength related to dose expression as Eribulin Mesilate salt or the active substance Eribulin.
It is unusual with this type of Dear Investigator Letter regarding risk of misdosing, but possibly something we will see more of.
The link to the document released today is here: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2012/02/WC500122926.pdf
5 days ago
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The EU Good Pharmacovigilance guidance first wave of draft documents are expected to come out around the 22nd February 12. This will include the following:
a) PV and Quality Systems
b) PV System Master file
c) ICSR including E2B
d) PSUR/PBRER and E2C rev 2
e) PASS
f) Risk Management
g) Signal Detection
11 days ago
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FDA has released a guidance on how to manage unsolicited requests for Off - Label information. You can find the new guidance on this link:
http://ottosen.com/library/item/fda-draft-guidance-on-reponding-to-information-requests
11 days ago
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Ottosen created a new topic UK legislation for implementation of EU PV dir in the forum.The UK proposal for new legislation is supposed to follow the directive and not add anything additional.
What is the assessement so far?
Read More...
70 days ago
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Does anybody have a "bridged" version of the two UK statutory instruments 2006 1928 for clinical trials and 2004 1031 as they are very hard to read with all the changes in a separate document
70 days ago
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a guest replied to the topic Re: PV master file content and implementation in the forum.I think there is more information now regarding the PV masterfile
At least for the DDPS is it clear that both MHRA and the EMA want the DDPS to be replaced completely by the masterfile and as soon as possible as they are drowning in variations at the moment
Read More...
82 days ago
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Ottosen created a new topic No report of endpoint cases not allowed in India in the forum.I have have "heard" that India may not allow for any trial SAE reports to remaind blinded or not reported even if they are study endpoints. This is the normal practice everywhere else to ensure the integrety of such trials
Do you have any information about this?
Read More...
84 days ago
