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PrimeVigilance Ltd
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News and Press Release - Source #EMA (European Medicines Agency): Meeting highlights from the #Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 May 2016 responsible for assessing all aspects of the risk management of medicines for human use in Europe is now available. To read more and to download the agenda http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002528.jsp&mid=WC0b01ac058004d5c1

News – PrimeVigilance is ready for the upcoming EMA launch of the new and improved version of EudraVigilance on 22 Nov 2017. Our Implementation Committee ensures our Client’s PV systems, and our internal tools and procedures are reviewed and updated according to the latest published requirements, and ready for the future revised two GVP modules VI and IX accompanying the EudraVigilance Business Change. PrimeVigilance also proudly offers training (DIA/EMA approved) and consultancy in this matter. For more information please contact us at info@primevigilance.com

News – PrimeVigilance is ready for the upcoming EMA launch of the new and improved version of EudraVigilance on 22 Nov 2017. Our Implementation Committee ensures our Client’s PV systems, and our internal tools and procedures are reviewed and updated according to the latest published requirements, and ready for the future revised two GVP modules VI and IX accompanying the EudraVigilance Business Change. PrimeVigilance also proudly offers training (DIA/EMA approved) and consultancy in this matter. For more information please contact us at info@primevivigilance.com

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Brexit News - PrimeVigilance is committed to minimising any impact of Brexit on our clients. Over the coming years, responsibilities of PrimeVigilance EEA QPPVs based in the UK will be transitioned to our EEA QPPV colleagues based in our EU offices (Frankfurt, Prague & Zagreb). We offer assistance with selection of the new PSMF location, and related choice of a new supervisory authority for EEA pharmacovigilance inspections. As the outcomes of Brexit negations are unclear, we will be keeping a close eye on developments to ensure continued quality & compliance. EMA link: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/general/general_content_001707.jsp&mid=WC0b01ac0580a809a7

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News and Press Release - Source #EMA (European Medicines Agency): Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 June 2017 responsible for assessing all aspects of the risk management of medicines for human use in Europe is now available. To read more and to download the agenda please click on the following link: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/06/news_detail_002761.jsp&mid=WC0b01ac058004d5c1

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If you are attending next week DIA 2017 Global annual meeting in Chicago, please stop by to say hello at our stand #2143 and meet our Team together with Dr Jan Petracek. For more information please contact us at bd@primevigilance.com or see https://lnkd.in/gxa2Vm8. We are looking forward to seeing you there!
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We are pleased to share a photo of the International Society of Pharmacovigilance #ISoP Mid-year Training Course 2017 held in Bangkok, Thailand on 25-26 May 2017, with Dr Jan Petracek together with other experts in the field of #pharmacovigilance from Taiwan, Singapore, New Zealand, Philippines, Sweden and the United Kingdom, a very successful and positive meeting!
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News brief – In November 2016, PrimeVigilance initiated its program of Change Request (CR) submissions to the MSSO to highlight the need for new terms or Standardised MedDRA Queries (SMQs) that we noted would be useful. The 56 requests submitted by PrimeVigilance during the first six months of its program have thus far led to 53 changes to MedDRA. PrimeVigilance has submitted CRs for 33 new LLTs, 19 new PTs, two PT moves to another place in MedDRA hierarchy, one new HLT and one new SMQ. For further information please see https://lnkd.in/g5TC4GT or contact us at info@primevigilance.com

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Please join Natalie Smith who is hosting a round table about “How to minimise follow-ups within the case management workflow to improve existing oversight programs” on June 14 at Proventa Pharmacovigilance Strategy Meeting Europe 2017 in London, UK. This event will be gathering over 100 C-Level Directors from a mix of emerging to large Pharma, Biotech & Research Institutions to help solve their key strategic challenges in the area of #Pharmacovigilance. For more information and sign up please visit https://proventainternational.com/pharmacovigilance-europe-2017

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News and Press Release - Source #EMA (European Medicines Agency): Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 May 2017 responsible for assessing all aspects of the risk management of medicines for human use in Europe is now available. To read more and to download the agenda please click on the following link: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/05/news_detail_002740.jsp&mid=WC0b01ac058004d5c1
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