FINAL QPPV Services - NDA Group · (QPPV) has in a company’s pharmacovigilance system to assure...
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In July 2012, the new Pharmacovigilance legislation came into force and highlighted the importance of the pivotal role that the EU qualified person in pharmacovigilance (QPPV) has in a company’s pharmacovigilance system to assure product safety. They are personally accountable for promoting, establishing, maintaining and improving compliance of a pharmacovigilance system for all EU authorised products throughout the product’s life span on the market. They must have oversight and influence over all operational activities concerning authorised products. How in practice can that occur? What does oversight mean? Do you know what an adequately qualified QPPV looks like? How does your Company ensure that your QPPV is fulfilling the requirements laid down in European legislation? Is your QPPV adequately resourced with backup which is equally competent? These are all fundamental questions for the management of a MAH wanting to place medicines in any EU market and to keep them there. So where can you go for expert advice? NDA has a range of solutions for the QPPV role to meet your needs: • Actually provide a QPPV or a deputy QPPV from our complement of highly skilled PV consultants. This can be provided as an interim or long-term solution. • Provide back-up processes for business continuity from one of our offices with consultants who are experienced at interacting with regulators. • Arrange training and mentoring for a QPPV to ensure they are qualified. • Audit the QPPV, identifying gaps in oversight and advising on optimal arrangements. • Our QPPVs will recommend corrective actions and continuous monitoring to ensure your PV system meets the requirements of the legislation. www.ndareg.com [email protected] | NDA Group | London | Munich | Stockholm QPPV Services “Having the right QPPV enhances regulatory confidence and helps management navigate the regulatory maze.” NDA consultants based at sites in Germany, Sweden and the United Kingdom will provide the best expertise and advice available in the market necessary to secure the integrity and suitability of the systems, people and processes within pharmaceutical companies to optimise product use and so protect patients. All our consultants have up to date knowledge of the changing regulatory requirements that pharmaceutical companies must comply with in order to ensure their products are safe and effective for patients. NDA can do this through a globally recognised portfolio of unique market services. Contact our Pharmacovigilance team: [email protected]
Transcript of FINAL QPPV Services - NDA Group · (QPPV) has in a company’s pharmacovigilance system to assure...
In July 2012, the new Pharmacovigilance legislation cameinto force and highlighted the importance of the pivotalrole that the EU qualified person in pharmacovigilance(QPPV) has in a company’s pharmacovigilance system toassure product safety. They are personally accountablefor promoting, establishing, maintaining and improvingcompliance of a pharmacovigilance system for all EUauthorised products throughout the product’s life span onthe market.
They must have oversight and influence over all operational activities concerning authorised products.How in practice can that occur? What does oversightmean? Do you know what an adequately qualified QPPVlooks like? How does your Company ensure that yourQPPV is fulfilling the requirements laid down in Europeanlegislation? Is your QPPV adequately resourced withbackup which is equally competent?
These are all fundamental questions for the managementof a MAH wanting to place medicines in any EU marketand to keep them there.
So where can you go for expert advice?
NDA has a range of solutions for theQPPV role to meet your needs:
• Actually provide a QPPV or a deputy QPPV from our complement of highly skilled PV consultants. This can be provided as an interim or long-term solution.
• Provide back-up processes for business continuity from one of our offices with consultants who are experienced at interacting with regulators.
• Arrange training and mentoring for a QPPV to ensure they are qualified.
• Audit the QPPV, identifying gaps in oversight and advising on optimal arrangements.
• Our QPPVs will recommend corrective actions and continuous monitoring to ensure your PV system meets the requirements of the legislation.
www.ndareg.com [email protected] | NDA Group | London | Munich | Stockholm
QPPV Services
“Having the right QPPV enhances regulatoryconfidence and helps management navigate the regulatory maze.”
NDA consultants based at sites in Germany, Swedenand the United Kingdom will provide the bestexpertise and advice available in the market necessary to secure the integrity and suitability of the systems, people and processes withinpharmaceutical companies to optimise product useand so protect patients.
All our consultants have up to date knowledge of thechanging regulatory requirements that pharmaceuticalcompanies must comply with in order to ensure theirproducts are safe and effective for patients.
NDA can do this through a globally recognisedportfolio of unique market services.
Contact our Pharmacovigilance team: [email protected]
FINAL QPPV Services 14/2/13 16:37 Page 1
www.ndareg.com [email protected] | NDA Group | London | Munich | Stockholm
QPPV Services
Professor Kjell Strandberg Dr Markku Toivonen Dr Panos Tsintis Graham Higson
Dr Peter Miller Dr Mary Teeling Dr Frits Lekkerkerker Dave Gilbert
Professor Bruno Flamion Paul Chamberlain Professor Peter Freeman Dr Manfred Haase
Dr Jenny Sims Dr Steffen Thirstrup Professor Beatriz Silva Lima Professor Bengt Jönsson
Professor Ron Akehurst Professor Frans Rutten Professor Martin Buxton Professor Ken Paterson
Professor Gérard de Pouvourville
Dr Lorenzo Mantovani Professor J.-Matthias Graf von der Schulenburg
NDA Advisory Boards Contact Us
If you are looking for answers to your drug developmentconcerns, the top level advice from NDA’s Advisory Boardsis unmatched in the market. These unique groups arecomprised of some of Europe’s most distinguishedregulatory and HTA experts - leaders in their fields.
Using our Advisory Boards allows you to get competent,unbiased answers and input into your development program,reducing risks and improving your chances for success.
The aim of this is to facilitate a fast and positive outcome toyour drug development program.
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