dia clinical safety & pharmacovigilance · 3. what can be done if mah has an english speaking...

3rd October 2018

DIA Clinical Safety & Pharmacovigilance Community Webinar

The Local QPPVPresented by:

Nimisha KotechaManaging Director/EU QPPV

IntuVigilance Limited

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IntuVigilance [email protected]

[email protected]

Nimisha Kotecha is a seasoned Drug Safety and PV expert with 19+ years in the Industry. She is the Managing Director at IntuVigilance Limited, a drug safety and PV service provider, working with CROs, Pharma and Biotech companies providing operational and strategic support for clinical trials as well as peri- and post-authorisation PV systems. Nimisha is a

member of a number of associations within our Industry, such as PIPA, ACRES, DIA, CIEHF, where she supports the advancement of Drug Safety and PV in various ways. Nimisha is

passionate about PV and strongly believes in delivering an impactful service whilst remaining intuitively vigilant of the regulatory perimeters within which we operate in the Industry.


http://www.intuvigilance.com/

mailto:[email protected]

mailto:[email protected]

The Local QPPV

The Role of the LQPPV:

The world of the QPPV is a fascinating and yet complex world, carrying enormous responsibilities that cascade

down from the European QPPV to national QPPVs. Nimisha has spent a number of years in the world of

QPPVs and PV Systems that are impacted by QPPVs, and provides her insight into what the role entails and how to

optimise your local PV system infrastructure to get the most out of your extended QPPV team.


Legal Basis


Directive 2010/84/EURegulation (EU) No 1235/2010Commission Implementing Regulation (EU) No 520/2012Good Vigilance PracticeAppropriate national laws and regulations

Legal Basis


Directive 2010/84/EU, Article 104:As part of the PV system, the MAH shall have permanently and continuously at his disposal, an appropriately qualified QPPV…. Reside and operate in the EU. [EU QPPV];In addition, national competent authorities may request the nomination of a contact person for pharmacovigilance issues at national level reporting to the EU QPPV responsible for phar-macovigilance; One local contact person per PSMF (having different distributors does not require different local contacts, if following the same PSMF);Required, regardless of authorisation procedure;Required at the point of MA Application, and not after market launch;Legal responsibility remains with the MAH;

Legal Basis

EMA/INS/PhV/445316/2017 Committees and Inspections ( 19 July 2017) –snapshot;

(17/30 Member States provide a legal basis for nominating a local QPPV; 12/30 do not specify a need for Local QPPVs; 1 provides no information);



Royal Decree of 28th May 2013 (FAMHP) and Circular 600

‘Local person responsible’ for PV – replaced with ‘local contact person’;Local contact person is linked to the EU QPPV and is responsible for local PV tasks in Belgium;Must have a professional address in Belgium, and a related telephone number;Does not have to be registered on a list set up by the minister; does not have to meet the demands in terms of diplomas nor does he have to submit proof or certification of any PV experience. However: Must be 24/7, must carry out PV tasks in Belgium, must have “adequate” experience in PV; necessary language skills i.e. must be able to converse with local partners in their national language as well as communicate with the EU QPPV; Must, at all times , be able to receive, handle, answer and follow up reports from Belgian citizens and HCPs at least in the three national languages ( French, Dutch, German);MAHs must submit to FAMHP declaration indicating the name and contact details of the designated local contact person and that they meet the requirements of 24/7 availability, etc. Annex 1 and II to be submitted to FAMHP;


Nomenclature Maze

So many names!

Estonia: EU QPPV is sufficient….but……..Estonian speaking local contact person required ( Regulation of the Minister of Social Affairs no.26 (§ 4 section 4);Cyprus: local responsible person for PV – specific qualification requirements;France: RPV (Reference Person) ‘required’ who lives and works in France; Specific qualifications; ANSM to be notified; BNPV (national database); National PV System; May be separate from ‘Responsible Pharmacist’;Netherlands: local PV contact person required; must be fluent in Dutch (speaking and writing); must be medically qualified or have access to a medically qualified person; UK: Named individual was always required by the MHRA;


Local QPPV or Contact Person-what do we know?

The need for local contact persons is sometimes stated in legislation (but not always);MAH is responsible for local safety surveillance activities in countries where their product is licensed;• Local literature surveillance;• Local safety contact for HCPs, Authority;• Local safety representative of the MAH;• Identified in PSMF ( state all responsibilities);• Available 24/7; Back-up person/process defined;• Must be able to take charge of local Inspections;• Actively input into PSMF;• Local medical information type activities?• Report to EU QPPV regularly – eyes and ears of the EU QPPV in the local

territory;• Support continuous monitoring of Benefit-Risk balance;


And therefore..

It goes without saying………Whether or not a country legislation specifically states the need for a Local QPPV, GVP clearly outlines the local responsibilities of the MAH………And at the very least, common sense dictates that a local PV contact person is identified in every licensed territory; Know the local legislation to help you assign your local contact person;Communicate with local persons regularly – don’t expect your local QPPV to always reach out first; Eyes and Ears…………


Qualify and Assess

Review your local contact person’s PV experience/training carefully –local contact persons charged with safety surveillance activities must be experienced in PV;

Qualify local persons diligently: ongoing PV training, Pertinent Operational Processes; Qualifications, Operational experience/ oversight; compliance metrics;

Local perspective is focused on safety surveillance within one national territory but the responsibility is crucial;

Local contact persons are often more operationally hands on than the EU QPPV; Ensure that the local person is knowledgeable and qualified to perform those local safety tasks;


Last but not least…

Local QPPV is not a role reserved for Member States – these days also prevalent in ROW countries;

Qualifications and level of interaction required by the national authority may vary considerably – know what is required;

Brexit-UK: UK QPPV will be required; EU MAHs will need to establish a UK legal presence and a UK QPPV ( variation); Not a ‘local’ QPPV, but a fully-fledged QPPV separate to the EU QPPV;

Questions – Detailed Answers provided during call

1. Can the local QPPVs put in place at the time of product approval? Yes.

2. Is local QPPV required irrespective of marketing status? What if the MAH does not commercialize any product in a particular country? Yes. GVP requires the MAH conduct local lit regardless of marketing status based on their license.

3. What can be done if MAH has an English speaking QPPV based in Netherlands? Do they still need a Dutch speaking local QPPV in Netherlands? If EU QPPV is fluent (reads and writes) Dutch, should be fine.

4. What is the speculation for a british pharmaceutical company (no licences anywhere else, only distributing to ROW countries)? will we need QPPVs or will it be responsible person? Answer provided during call


5. Should there be a firm list of local journals that should be screened for monitoring local literature by local QPs? And

should that be a part of PSMF? Yes, a list of local journals should be maintained and updated regularly. Does not need to go into PSMF;

6. In follow-up to Q2, If the MAH does not commercialize in a

given country, it would be expected that there would be no local literature generated related to the product since no

product is available on the market; please confirm. No. The point is to look at class affect which could have an impact on your license.

7. Where can we get the list of L-QPPV requirements? Link will be provided to community

8. Are there any provision in regulations that a single local QPPV can cover multiple countries? Answer provided during call


9. Can the local / Australian QPPV have oversight of AuA L-QPPVs if they have direct contact with the EU QPPV? Yes, as long as the EU QPPV has timely access/insight to the information & updates in that region.

10. With these changes, is it appropriate for the Local QPPVs to report to the CMO or should there be a “QPPV Office”? An “Office of the QPPV” is a great idea. Local QPPVs typically don’t report to the CMO, they report to the EU QPPV who typically reports to the CMO.

11. How many Member States require a LQPPV? 17 (comes from EMA List)

12. if 17 MS required LQPPV. Can we extrapolate that these countries only require local literature monitoring? Local Literature monitoring is required in every member state as outlined in GVP.

13. I believe for Belgium the local QPPV needs a local phone number (+32..). What do we mean by professional address in Belgium? A Working address/office in Belgium.



14. In general, is there a sufficient number of local QPPVs to support the current and growing demand? In opinion, yes. Ensure they are adequately qualified and trained (continuously).

15. Is there standardized QPPV/LQPPV training? Nothing globally formalized, however There are Core competencies for QPPVs, from IAOCR...http://iaocr.com/wp-content/uploads/2016/04/Core-Global-Competency-Standards-for-QPPV.pdf


http://iaocr.com/wp-content/uploads/2016/04/Core-Global-Competency-Standards-for-QPPV.pdf

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