Author: devadmin2

News brief: 02-Jun-2017
Prepared by:
Jennifer Parish, MD MPH, Certified MedDRA Coder
Cvijeta Bielen, MD, Medical Director
Medical Dictionary for Regulatory Activities (MedDRA) is maintained by the MedDRA Maintenance and Support Service Organisation (MSSO), and all MedDRA users are welcomed to submit Change Requests (CRs) with the goal of improving this dictionary to better meet user requirements. The MSSO utilises user-submitted CRs along with its internal review processes to update and maintain MedDRA with bi-annual versioning. All CRs receive a written response indicating the MSSO decision, many of which also include the rationale for rejecting or changing the original CR. WebCR is the online tool created for the management of CRs. This portal allows users to manage their own CRs as well as search the archive of CR submissions to view their corresponding responses from the MSSO.
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. This includes terms that were accepted as-requested, those that were accepted after being slightly modified by the MSSO, and those terms that were added by the MSSO as ‘related-changes.’ 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. Some of the approved CRs have included the addition of LLT Accidental occupational exposure, LLT Full-thickness chemical burn, PT Malignant glaucoma, and PT Tissue discolouration. The assessment of the proposed SMQ Acquired Fanconi Syndrome CR remains pending.
PrimeVigilance strives to provide the highest quality and accuracy in all aspects of pharmacovigilance, including MedDRA coding. The company has found that the data available on the MedDRA WebCR portal, as well as replies it has received to its CR submissions, are already providing PrimeVigilance valuable insight into further enhancing its use of MedDRA for data coding and retrieval.
Please feel free to contact us with any questions at info@primevigilance.com.

PrimeVigilance & PharmInvent´s CEO Dr Jan Petracek will be teaching alongside Dr. Michael Forstner at the DIA Training course titled: Benefit Risk Management.
Dr. Petracek belongs to the best-in-class instructors at #DIA. He has a long history of professional trainings and speaking courses at DIA events worldwide, and enjoys participating in these focused trainings that concentrate on educating members of the pharmacovigilance industry.
This training takes place on April 24-25, 2017.  The location is Berlin, Germany.
The attendees will learn:

• Legal possibilities for benefit optimization and risk minimization of products in the EU
• Designing Benefit-Risk management systems using current regulatory tools, including EU Risk Management Plans (EU-RMPs), Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR)
• Best study designs for safety and efficacy follow-up, and how to measure their effectiveness

Professionals most likely to benefit from this training are those in charge of the design and maintenance of risk management systems, pharmacovigilance auditing or inspecting, Qualified Persons for Pharmacovigilance (QPPVs) and heads of Benefit-Risk management, patient safety, or lifecycle management.
Details of the event are posted on the DIA Website.

PrimeVigilance Press Release
PrimeVigilance Management Changes
 Guildford, UK – 13 April 2017
PrimeVigilance is pleased to announce that Dr. Jan Petracek will step into the role of Chief Executive Officer of PrimeVigilance. Jan joined the Ergomed group, the owners of PrimeVigilance, in November 2016 as CEO of European PharmInvent Services s.r.o. following its acquisition and subsequent integration into PrimeVigilance.
Neil Clark will step down as CEO of PrimeVigilance with effect from 16 April 2017. Neil is leaving to become Chief Executive Officer of Destiny Pharma Limited, a company focused on the discovery, development and commercialisation of novel antimicrobials. Neil will remain on the Board of PrimeVigilance, as a non-executive director and a consultant during a transition period.
Dr. Miroslav Reljanovic, Chief Executive Officer of Ergomed, said:
 “I would like to give my sincere thanks to Neil for his eight years’ service to Ergomed. He has helped the Company transition from a private company through the IPO process in 2014 and latterly, overseen a period of strong growth in PrimeVigilance. I wish him all the best in the next stage of his career.
“We are fortunate to have in the wings a replacement CEO of the calibre of Dr. Jan Petracek. As founder of PharmInvent and former regulator at EMA, his unique combination of entrepreneurship and specialist pharmacovigilance expertise will serve to drive forward our pharmacoviglance businesses.”
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 About PrimeVigilance

 PrimeVigilance is a Pharmacovigilance (PV) and Medical Information Services company with an established international footprint and a heritage of excellence and leadership in the field of pharmacovigilance.
PrimeVigilance was established in 2008 and offers a comprehensive, top quality, cost-effective, innovative safety services for pharmaceutical, generic and biotechnology companies. Our founders have an unrivalled reputation in the sector with a network of expert associates across the world. These include former senior regulators and consultants with extensive industry experience, especially with marketed products.

Expert pharmacovigilance services

The pharmacovigilance services offered by PrimeVigilance cover all the regulatory and scientific elements of PV required to obtain and maintain a product licence within Europe: Qualified Person, Risk Management Planning (RMP), and a compliant PV System with consistent Adverse Event data capture, robust Quality Management, expedited reporting, preparation of PSURs, literature screening, signal detection and evaluation, benefit-risk assessment, compliance auditing, support during crisis and various ad hoc assignments. PrimeVigilance also offers fully integrated international Medical Information service.
PrimeVigilance specialises in helping emerging companies comply with regulations, from developing the initial PSMF and RMP to full management of safety operations.

A global reach

PrimeVigilance has grown organically since 2008 and now has now over 350 staff employed in its main offices in UK, Europe and USA, as well as an international network of consultants. PrimeVigilance is currently providing services across 100 countries.
For more information contact PrimeVigilance or visit www.primevigilance.com

About Ergomed

Ergomed plc is a profitable UK-based business providing drug development services to the pharmaceutical industry and has a growing portfolio of co-development partnerships. It operates in over 50 countries.
Ergomed provides clinical development, trial management and pharmacovigilance services to over 100 clients ranging from top 10 pharmaceutical companies to small and mid-sized drug development companies. Ergomed successfully manages clinical development from Phase I through to late phase programmes.
Ergomed has a wide therapeutic focus, with a particular expertise in oncology, neurology and immunology and the development of orphan drugs. Ergomed believes its approach to clinical trials is differentiated from that of other providers by its innovative Study Site Management model and the use of Study Physician Teams, resulting in a close relationship between Ergomed and the physicians involved in clinical trials.
As well as providing high quality clinical development services, Ergomed is building a portfolio of co-development partnerships with pharma and biotech companies which share the risks and rewards of drug development. Ergomed leverages its expertise and services in return for carried interest in the drugs under development. Lastly, Ergomed recently acquired a pipeline of proprietary development products for haemostasis in surgical settings. For further information, visit: https://ergomedplc.com.

PrimeVigilance Press Release

PrimeVigilance and PharmInvent combine to create leading, international full service pharmacovigilance, medical information and regulatory service provider
London, UK/Prague, CZ – 29 November 2016: PrimeVigilance and PharmInvent are pleased to announce that they are now working together as an integrated service provider following the acquisition of PharmInvent by Ergomed plc, the owner of PrimeVigilance.
The companies will continue to trade under their current names and there will be no changes to any of the existing client arrangements, including staffing or any other business relationships.
There is however clear intention to share expertise and ensure that existing clients continue to receive the highest standards of service and also to introduce new services or expertise where appropriate and also to attract new clients from across the globe. The combination of PharmInvent and PrimeVigilance creates one of the world’s largest specialist drug safety service providers with over 300 highly qualified staff based in UK, Europe and USA. The combined range of service offerings is excellent with both companies benefiting from the additional skills that the other party brings to the enlarged business.
Neil Clark, Chief Executive Officer of PrimeVigilance Ltd, commented: 
“This synergistic combination of PharmInvent with PrimeVigilance creates a business with a market-leading position in the provision of outsourced pharmacovigilance services for clients developing or selling drug products across the world. The enhanced service offering and mutual focus on high quality will ensure that existing and new clients continue to receive the best advice and service”.
Jan Petracek MD, Chief Executive Officer of PharmInvent, said:
“These are very exciting times for PharmInvent. We have spent the last six years building our business and reputation and now look forward to significantly leveraging our position working alongside PrimeVigilance. Together, our skills will allow us to seize significant new opportunities as well as expand our offering to our existing customer base. “
PharmInvent will continue to be led by its founders, Dr Jan Petracek and Dr Martin Votava. Dr Petracek was formerly a Head of the Risk Management Section at the European Medicines Agency (EMA), while Dr Votava represented the Czech Republic in the Committee for Medicinal Products for Human Use at the EMA.
CEO of PharmInvent, Dr Jan Petracek, will join the Board of PrimeVigilance. Neil Clark, CEO of PrimeVigilance, will join the Board of PharmInvent.
In addition, Dr Jan Petracek has been appointed as non-executive director and President of PrimeVigilance.
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About PrimeVigilance

 PrimeVigilance is a Pharmacovigilance (PV) and Medical Information Services company with an established international footprint and a heritage of excellence and leadership in the field of pharmacovigilance.
PrimeVigilance was established in 2008 and offers comprehensive, top quality, cost-effective, innovative safety services for pharmaceutical, generic and biotechnology companies. Our founders have an unrivalled reputation in the sector with a network of expert associates across the world. These include former senior regulators and consultants with extensive industry experience, especially with marketed products.

Expert pharmacovigilance services

The pharmacovigilance services offered by PrimeVigilance cover all the regulatory and scientific elements of PV required to obtain and maintain a product licence within Europe: Qualified Person, Risk Management Planning (RMP), and a compliant PV System with consistent Adverse Event data capture, robust Quality Management, expedited reporting, preparation of PSURs, literature screening, signal detection and evaluation, benefit-risk assessment, compliance auditing, support during crisis and various ad hoc assignments. PrimeVigilance also offers fully integrated international Medical Information service.
PrimeVigilance specialises in helping emerging companies comply with regulations, from developing the initial PSMF and RMP to full management of safety operations.

A global reach

PrimeVigilance has grown organically since 2008 and now has over 250 staff employed in its four main offices in Guildford UK, Zagreb, Croatia, Boston, USA and Belgrade, Serbia. As well as an international network of consultants .PrimeVigilance is currently providing services across 100 countries.
For more information contact PrimeVigilance today www.primevigilance.com

About PharmInvent

PharmInvent provides high quality and value-for-money services in pharmacovigilance, pharmaceuticals risk management, regulatory science and clinical development to the pharmaceutical industry, contract research organizations, academia, the healthcare industry, and national government organizations. PharmInvent has achieved global geographical coverage focusing on ICH regions, and operates ISO 9001:2015 certified quality management system.
PharmInvent‘s specialists share their insights and expertise at training courses, seminars and conferences organized by international pharmaceutical societies on 4 continents. They have trained thousands of industry professionals on the best practices in pharmacovigilance and regulatory compliance and have cooperated closely with numerous regulatory agencies around the world.
PharmInvent has grown organically since 2010 and now totals over 60 employees along with an international network of about 90 PV experts from over 50 countries. The management of PharmInvent consists of pharmacovigilance and regulatory experts with vast experiences from the European Medicine Agency, National Competent Authorities, and the pharmaceutical industry. To learn more about PharmInvent and the services offered, please visit www.pharminvent.com .