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Mar25
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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=
85 days 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
85 days 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
85 days 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
87 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
90 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
90 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
90 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
95 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
95 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...
154 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
154 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...
167 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?
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168 days ago
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Ottosen replied to the topic Re: Interpretation of the June 2011 CT3 in the forum.I wonder how to interpret CT-3Section 4.4 which tates: Start and end of reporting serious adverse events to the sponsor: Serious adverse events occurring to a subject after the treatment of that subject has ended should be reported to the sponsor if the investigator becomes aware of them (16) - where (16) is a reference to section 3.E.3 of the note for guidance ICH E2A.
Does this mean that the investigaor have have to report serious adverse events for ever after the trial have closed?
This is contradicting E2A which is actually written into law in the 3 ICH regions which states that:
ICH E2A Section 3.E.3:
3. Post-study Events, Although such information is not routinely sought or collected by the sponsor, serious adverse events that occurred after the patient had completed a clinical study (including any protocol-required post-treatment follow-up) will possibly be reported by an investigator to the sponsor. Such cases should be regarded for expedited reporting purposes as though they were study reports. Therefore, a causality assessment and determination of expectedness are needed for a decision on whether or not expedited reporting is required.
Here it says possibly which would make sense as there no longer is a formal study to ensure active reporting.
How are you managing this?
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168 days ago
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Ottosen created a new topic Interpretation of the June 2011 CT3 in the forum.I wonder how many are struggeling with the interpretation of the newly issued CT3 which is part of the EU Volume 10.
There seems to be a lot of inconsistencies in the text which I would like to hear how you have interpreted.
Read More...
168 days ago
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a guest replied to the topic Re: PV master file logbook of changes in the forum.test
Read More...
178 days ago
