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Quality Systems For Pharmacovigilance SME Workshop "Focus On Pharmacovigilance" 19 April 2012, EMA London

This document summarizes the key elements of quality systems for pharmacovigilance as outlined in recent EU legislation and guidance. It describes the minimum requirements for quality systems including their scope, performance indicators, management of human resources, compliance, record keeping, and auditing. The guidance provides details on quality system structures and processes, and the operation of quality systems within the EU regulatory network for pharmacovigilance. Maintaining an effective quality system is important to assure the integrity of pharmacovigilance systems and produce reliable outcomes that protect public health.

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Hala Mohamed
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188 views20 pages

Quality Systems For Pharmacovigilance SME Workshop "Focus On Pharmacovigilance" 19 April 2012, EMA London

This document summarizes the key elements of quality systems for pharmacovigilance as outlined in recent EU legislation and guidance. It describes the minimum requirements for quality systems including their scope, performance indicators, management of human resources, compliance, record keeping, and auditing. The guidance provides details on quality system structures and processes, and the operation of quality systems within the EU regulatory network for pharmacovigilance. Maintaining an effective quality system is important to assure the integrity of pharmacovigilance systems and produce reliable outcomes that protect public health.

Uploaded by

Hala Mohamed
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Quality systems for pharmacovigilance

SME Workshop “Focus on Pharmacovigilance”

19 April 2012, EMA London

Presented by: Suvi Loikkanen


Senior Pharmaceutical Officer, Finnish Medicines Agency (FIMEA)

An agency of the European Union


References

Legislation

Directive 2010/84/EU amending Directive 2001/83/EU

Regulation (EU) No 1235/2010 amending Regulation (EU) No 726/2004

Commission Implementing Regulation (final not yet published)

Guidance

GVP Module I – Pharmacovigilance systems and their quality systems

2
Directive 2010/84

Article 108

”In order to harmonise the performance of the pharmacovigilance


activities provided for in this Directive, the Commission shall adopt
implementing measures in the following areas for which
pharmacovigilance activities are provided for in Article 8(3), and in
Articles 101, 104, 104a, 107, 107a, 107b, 107h, 107n and 107p:

(b) the minimum requirements for the quality system for the
performance of pharmacovigilance activities by the national
competent authorities and the marketing authorisation holder; ”
3
Regulation (EU) No 1235/2010

Article 87a

” In order to harmonise the performance of the pharmacovigilance


activities provided for in this Regulation, the Commission shall adopt
implementing measures as provided for in Article 108 of Directive
2001/83/EC covering the following areas:
…
(b) the minimum requirements for the quality system for the
performance of pharmacovigilance activities by the Agency;”

4
Commission Implementing Regulation

Article 9 Scope of the quality system

1. Established and followed quality system that is adequate and


effective for performing pharmacovigilance activities

2. Covers organisational structure, responsibilities, procedures,


processes and resources and includes appropriate resource
management, compliance management and record management

3. Based on quality planning, quality control, quality assurance and


quality improvements

4. Documented in a systematic and orderly manner in the form of


written policies and procedures
5
Commission Implementing Regulation

Article 10 Performance indicators

1. May be used to continuously monitor the good performance of


pharmacovigilance activities
• documentation in an annex to the pharmacovigilance system
master file

2. The Agency may publish a list of performance indicators on the


basis of a recommendation of the Pharmacovigilance Risk
Assessment Committee

6
Commission Implementing Regulation

Article 11 Management of human resources

1. A sufficient number of competent and appropriately qualified and


trained personnel

Qualified person responsible for pharmacovigilance has a acquired


adequate theoretical and practical knowledge for the performance of
the pharmacovigilance activities
• assisted by a medically trained person if not completed basic
medical training in accordance with Art. 24 Dir. 2005/36/EC

7
Commission Implementing Regulation

Article 11 Management of human resources

2. Job descriptions defining the duties of the managerial and


supervisory staff, including the qualified person responsible for
pharmacovigilance

Organisational chart defining hierarchical relationships

Qualified person responsible for pharmacovigilance has sufficient


authority to influence the performance of the quality system
and the pharmacovigilance activities of the marketing
authorisation holder

8
Commission Implementing Regulation

Article 11 Management of human resources

3. Initial and continued training in relation to the role and


responsibilities

Training plans and records for documenting, maintaining and


developing competencies and for audit or inspection

4. Appropriate instructions on processes for dealing with urgent


situations, including business continuity

9
Commission Implementing Regulation

Article 12 Compliance management

a) Continuous monitoring of pharmacovigilance data and consideration


of options for risk minimisation and prevention

b) Scientific evaluation of all information on the risks of medicinal


products

c) Timely submission of data on adverse reactions to the Eudravigilance

d) Effective communication with NCA and Agency

e) Up to date product information with current scientific knowledge

f) Communication of relevant safety information HCPs and patients


10
Commission Implementing Regulation

Article 12 Compliance management

2. Where a marketing authorisation holder has delegated certain tasks


of its pharmacovigilance activities, it shall retain responsibility for
ensuring that an effective quality system is applied in relation to
those tasks

11
Commission Implementing Regulation

Article 13 Record management and data retention

1. For all documents used for pharmacovigilance activities


• Ensuring the retrievability and the traceability of how safety
concerns have been investigated, the timelines for these
investigations and how and when decisions have been taken
• Allowing accurate reporting, interpretation and verification of the
pharmacovigilance information
• Enabling the traceability and follow-up of adverse reaction reports
while complying with data protection legislation
2. Documents retained at least 5 years (system) or 10 years (product)

3. Documentation arrangements documented in PSMF


12
Commission Implementing Regulation

Article 14 Audit

1. Risk-based audits at regular intervals

Conducted by individuals who have no direct involvement in or


responsibility for the matters being audited

2. Corrective actions and follow-up audit of deficient matters

Audit report of the results of each audit and follow-up audit


reviewed by the management responsible for the matters audited

13
GVP Module I
Pharmacovigilance systems and their quality systems

Guidance for the establishment and maintenance of quality assured


pharmacovigilance systems

Marketing authorisation holders


Competent authorities of Member States
Agency

Describes general application of quality management to


pharmacovigilance systems and requirements specific to the operation
on EU network

14
Key elements of the Module I
Structures and prosesses

Overall quality objectives for pharmacovigilance

Principles for good pharmacovigilance practices

Responsibilities

Training

Facilities and equipment

Compliance management

15
Key elements of the Module I
Structures and prosesses

Record management

Documentation

Critical pharmacovigilance processes

Monitoring performance and effectiveness

Preparedness planning

16
Key elements of the Module I
Operation of the EU network

Applicant and marketing authorisation holder

Overall pharmacovigilance responsibilities (EU)

Responsibilities in relation to the QPPV

Specific quality system processes

Quality system requirements for delegated pharmacovigilance tasks

Qualified person responsible for pharmacovigilance (QPPV)

Qualifications

Role
17
Key elements of the Module I
Operation of the EU network

EU regulatory network

Competent authorities in Member States

European Commission

European Medicines Agency

Pharmacovigilance Risk Assessment Committee (PRAC)

Committee for Medicinal Products for Human Use (CHMP)

Coordination Group for Mutual Recognition and Decentralised Procedures


(CMDh)
18
Conclusion

Quality system is to assure the integrity of the pharmacovigilance


system and is an integral part of the pharmacovigilance system

Produce visibly good pharmacovigilance


Public health
Overall confidence
Public trust

19
Thank you !

20

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