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Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Each chapter and revisions are developed by a team consisting of experts from EMA and from EU Member States.For other templates developed outside the GVP process, see: The PBRER is accepted by most countries, even those that provide specific local report templates, MAH, PSUR, GVP Module VII, ICH Guidance Topic on PBRER, European Regulatory Network Understand and apply all major concepts relating to benefit risk evaluation, modular and risk based approach ©2009-2020 Eu2P - European programme in Pharmacovigilance and Pharmacoepidemiology.

They cover medicines authorised centrally via the Agency as well as medicines authorised at national level.

Explanatory Note to GVP Module VII (March 2017) This new explanatory note to GVP Module VII explains the purpose and requirements of key sections of the PSUR. (��{ �Z���aHB��I�mb��"l����p ������"����8���" h7;sr�L?o4�М�ͳ��n(!ֳ��l��{��x�#Z?J$�Ga!� �;�p����c�a��t�v���n�N;�11��]�����!��ʹ���/�u�7>�m� @���`�������� ��@, The EMA has released (June 2012) the new “Guideline on Good Pharmacovigilance Practices (GVP) – Module VII – Periodic Safety Update Reports” which covers the new requirements for the submission of post-approval (post-authorization) aggregate reports. Why do I need to know this? : MAH, PSUR, GVP Module VII, ICH Guidance Topic on PBRER, European Regulatory Network . If you continue browsing the site, you agree to the use of cookies on this website.

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This can be the PBRER in the EU (GVP module VII) and most Eastern European countries, the Periodic Adverse Drug Experience Report (PADER) in the US, or the Annual Safety Report (ASR) in Canada.

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PSUR sub-section “Important baseline efficacy and effectiveness information”

A few thoughts on work life-balance 4156 0 obj <>/Filter/FlateDecode/ID[<9372396B3C2A0F499D98C8C253012FDD><8D2E64A9B1986A4390091DFB0F06D1D6>]/Index[4133 42]/Info 4132 0 R/Length 110/Prev 469242/Root 4134 0 R/Size 4175/Type/XRef/W[1 3 1]>>stream In addition to GVP Module VII, ICH This short course has been added to your Study List:

Trillion Dollar Coach Book (Bill Campbell) of marketing approval. , EMA… %%EOF APIdays Paris 2019 - Innovation @ scale, APIs as Digital Factories' New Machi... The objective of this training is to enable you to better understand the obligations of MAH's on Periodic Safety Update Reports so often called PSUR as described in the GVP Module VII - Rev 1.

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Module VII of the Guidelines on Good Pharmacovigilance Practices (GVP) provides guidance on the preparation, submission and assessment of PSURs.

If the site still contains content that does not yet reflect the withdrawal of the UK from the EU, this is unintentional and will be addressed. %PDF-1.5 %���� The Periodic Benefit-Risk Evaluation Report (PBRER) described in this guideline is intended to be a common standard for periodic benef it-risk evaluation reporting on marketed products (including approved drugs that are under further study) among the ICH regions. VII.A. We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. Guideline on good pharmacovigilance practices (GVP) – Module VII EMA/816292/2011 Page 3/65 VII.B.5.17.1. Medicinal Products in the European Union), which has, up to July 2012, governed the content of the EU PSUR, has been made redundant and replaced by new guidance known as Good Pharmacovigilance Practices (GVP) [3]. Scribd will begin operating the SlideShare business on September 24, 2020 Now customize the name of a clipboard to store your clips.


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