2015_pv support by dada

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Pharmacovigilance support

DADA Consultancy B.V.

2015

DADA Consultancy B.V.

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DADA Consultancy B.V. Our aim is to provide state-‐of-‐the-‐art regulatory affairs and pharmacovigilance services and to establish long-‐term partnerships with our international clients. DADA Consultancy is a premier and independent consulting agency, based in Nijmegen, The Netherlands, since 1984. We focus on our customers and connect you to our experienced staff, who have a scientific (biomedical) background and provide quality services in their field of expertise.

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DADA Consultancy B.V. DADA offers a full range of tailor-‐made developmental and international regulatory affairs and pharmacovigilance services At DADA we have a passion for detail while maintaining focus on our client’s ultimate goal.

We have extensive experience in communicating with Health Authorities.

Covering all European Member States and related regulated markets.

Long-‐lasting partnerships with external experts to provide optimal support.

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Pharmacovigilance Activities •  Purpose of PV activities:

• to enable detection of new safety signals • to enable monitoring of already detected safety issues • to facilitate the preparation of reports to authorities

Ultimate goal: Provide competent authorities with an up-‐to-‐date, objective overview of the safety profile of a medicinal product. •  In this way, ensure that the product’s marketing authorization can be

maintained through early detection and proper management of safety issues.

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Regulations and Guidelines •  The legal basis for PV:

–  Council Directive 2001/83/EC (National/MRP, amended by Directive 2004/27/EC, recently by 2010/84)

–  Regulation 726/2004 (centralized, replaced Reg. 2309/93, recently amended by 1235/2010)

•  Guidelines: –  Good Vigilance Practices, Volume 9B –  International Conference on Harmonization (ICH: E2A, E2B, E2B M,

E2C, E2D, M1) –  Council for International Organizations of Medical Sciences (CIOMS) I

to IX –  CHMP, CVMP, HMPC, PhVWP(V), PRAC etc.

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Pharmacovigilance System •  A pharmacovigilance system is defined as a system used by an organisation

to fulfill its legal tasks and responsibilities in relation to pharmacovigilance and designed to monitor the safety of authorised medicinal products and detect any change to their risk-‐benefit balance;

•  complying with the legal requirements for pharmacovigilance tasks and responsibilities;

•  preventing harm from adverse reactions in humans arising from the use of authorised medicinal products within or outside the terms of marketing authorisation or from occupational exposure;

•  promoting the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public; and

•  contributing to the protection of patients’ and public health.

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Regulations and Guidelines The Qualified Person for Pharmacovigilance (QPPV) Directive 2001/83/EC (Title IX, Article 103): “The marketing authorization holder

shall have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance.”

Responsibilities (GVP Module I – PV systems and their QMSs): •  establish and maintain the Marketing Authorisation Holder’s

pharmacovigilance system; •  have an overview of the safety profiles and any emerging safety

concerns in relation to the medicinal products for which the Marketing Authorisation Holder holds authorisations OR has applied for an authorisation;

•  act as a single contact point for the Competent Authorities on a 24-‐hour basis;

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Pharmacovigilance Support •  EU Qualified Person for Pharmacovigilance (QPPV)

•  Within the EU, each Marketing Authorisation Holder should ensure that they have a single point of contact, with a deputy, that is available 24/7 to act as the Qualified Person for Pharmacovigilance (QPPV).

•  The QPPV must be permanently and continuously at the disposal of the MAH and must be experienced in all aspects of pharmacovigilance. The QPPV must reside and operate within the EEA, and a deputy may be needed as well.

•  In several EU countries, a local responsible person for PV is required.

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Approach DADA:

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Pharmacovigilance Activities •  DADA PVD performs PV on the active substance, i.e. all relevant safety

information on the active substance is collected (independent of marketing status) -‐ reporting only on products for which ‘ownership’ of the client cannot be excluded.

•  Collecting, processing, assessing, forwarding and as necessary

expedited reporting of ICSRs (incl. SUSARs(=clinical serious unexpected ICSRs)) with a dedicated PV database –  from different origins: authorities -‐ clinical studies -‐ commercial partners -‐ health care

professionals (HCPs) -‐ patients / consumers -‐ WW scientific literature -‐ etc.

•  Electronic reporting in the EEA: –  Computer-‐to-‐computer talk via “.xml” files –  Compulsory since Nov 2005 –  Exchange pre-‐ and post-‐authorisation PV data between:

•  EMA •  Competent Authorities •  Pharmaceutical Companies

–  DADA has registered on behalf of client(s) with EVWEB environment for electronic reporting of (non-‐)serious ICSRs and SUSARs

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Pharmacovigilance Activities •  Literature screening of local and worldwide published medical and

scientific literature for: –  Identification of ICSRs/case reports –  Identification of safety information from animal/clinical/post-‐marketing/

pharmacoepidemiological studies/safety reviews

•  Ongoing Signal detection and evaluation –  Identification of underlying trends or safety issues that require notification of

Competent Authorities –  In close collaboration with RPPV and client management

•  Periodic Safety/Risk Management Reports preparation

–  Risk-‐benefit evaluation and summary of important identified safety information –  Presentation of identified signals –  Comprehensive review of all obtained safety information, set to patient exposure

estimates and assessed against established safety profile –  DADA will prepare and submit these reports on behalf of client per EU Union

Reference Dates, as applicable

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Pharmacovigilance Activities •  Writing of Addenda to the Clinical Overview for renewal procedures •  Referrals per PRAC and/or NCAs requiring answer documents •  Population and maintenance of the XEVMPD (eXtended EudraVigilance

Medicinal Product Dictionary, Article 57 Reg.) •  Responding to requests from Competent Authorities •  Set up PV Safety Data Exchange Agreements/Statements

to lay down the different responsibilities of –  distributors –  client for the exchange of ICSRs, SUSARs, PSURs/DSURs, RMPs, line listings, opinions, etc.

including the time-‐frames for exchange

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•  Pharmacovigilance Training

–  from basic pharmacovigilance for general awareness, to dedicated training for staff most likely to be informed of safety information

•  SOP/WI writing

–  assist in the preparation or review of standard operating procedures, up to the level of

–  assisting in the creation of an in-‐house pharmacovigilance system

•  Audit of the client’s PV system, e.g. in preparation for inspections •  Pharmacovigilance Advice

Pharmacovigilance Activities

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Tailormade approaches -‐ 1

Client

Sales

R&D

QA

Website

Reception desk

Safety information

Distributor

Licensing

Co-marketing

- SDEAs

DADA - QPPV, 24/7 availability - signal detection

- literature screening

Competent authorities

PSURs DSURs

ICSRs RMPs

Contact person - RPPV

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Client’s PV dept

Sales

R&D

QA

Website

Reception desk

Safety information

Distributor

Licensing

Co-marketing

- SDEAs

DADA - QPPV, 24/7 availability

- signal detection



PSURs DSURs

ICSRs RMPs

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Client’s PV dept

Sales

R&D

QA

Website

Reception desk

Safety information

Distributor

Licensing

Co-marketing

- SDEAs - signal detection



PSURs DSURs

ICSRs RMPs

- QPPV, 24/7 availability

- Local ICSR tracking and follow-up - PSURs/ DSURs/RMPs/Adds to CO preparation

DADA -  Local literature screening

- Local contact point for MI/PC/AE

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Client’s PV dept

Clients Clinical department(s)

Safety information

- SDEAs - signal detection



RMPs

- QPPV, 24/7 availability

-  Data monitoring

-  Clinical case processing

Client’s CRO

DADA - Clinical Study Report / DSUR preparation

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Contact

•  For pharmacovigilance questions, refer to: –  www.dada.nl –  +31(0)24 3730 309 –  E-‐mail: [email protected]

2015_pv support by dada

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