Training session on the new pharmaceutical legislation, European - - PowerPoint PPT Presentation

An agency of the European Union

Pharm acovigilance legislation: Our im plem entation journey…

Training session on the new pharmaceutical legislation, European Medicines Agency 29 November 2012

Franck Diafouka, Project Manager, Pharmacovigilance and Risk Management, Patient Health Protection, EMA

1

• Our implementation journey: where are we?
• Our implementation journey: where are we

going?

• Conclusion

Content

2

I m plem entation journey….

PSUR PASS PAES Article 5 7 PASS RMP I nspections Pharm acovigilance audits Additional m onitoring EURD list Black sym bol Signal detection Referrals PRAC Pharm aco

• vigilance

system s ADR reporting Safety announ- cem ents CHMP W eb form s Renew al Literature m onitoring Fees EudraVigilance Coordination Group EC decision Agendas Minutes EMCDDA I m plem enting regulation RoP Lists Public hearings EU m edicines w eb-portal PRAC Mandate Fees Drug abuse Medication errors Public health EMA Mem ber States Signals Lists PRAC advice PRAC recom m en

• dation

PHARMACOVIGILANCE

Good pharm acoVigilance practice ( GVP)

Key achievem ents

Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Business processes I nform ation and Com m unication Tools

Key achievem ents

Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Business processes I nform ation and Com m unication Tools

Technical Contribution (June 2011)

Key achievem ents

Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Business processes I nform ation and Com m unication Tools

Reflection papers

Key achievem ents

Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Business processes I nform ation and Com m unication Tools

Reflection papers Good pharmaco- Vigilance Practice

Key achievem ents

Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Business processes I nform ation and Com m unication Tools

Reflection papers Good pharmaco- Vigilance Practice Guidance documents

Key achievem ents

Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Business processes I nform ation and Com m unication Tools

Reflection papers Good pharmaco- Vigilance Practice Guidance documents Questions and Answers documents

Key achievem ents

Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Business processes I nform ation and Com m unication Tools

Reflection papers Good pharmaco- Vigilance Practice Guidance documents Questions and Answers documents Working agreement

10

• Article 28c(2): ‘The Agency and the EMCDDA shall exchange

information that they receive on the abuse of medicinal products including information related to illicit drugs’.

• Working arrangement (first signed in 2010) amended by EMA

and EMCDDA Directors to strengthen information-exchange practices.

• More timely response to potential public health threats

W orking agreem ent to enhance cooperation w ith EMCDDA*

* EMCDDA: European Monitoring Centre for Drugs and Drug Addiction

Key achievem ents

Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Business processes I nform ation and Com m unication Tools

Reflection papers Good pharmaco- Vigilance Practice Guidance documents Questions and Answers documents Working agreement Rules of Procedure and Mandates

Key achievem ents

Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Business processes I nform ation and Com m unication Tools

Reflection papers Good pharmaco- Vigilance Practice Guidance documents Questions and Answers documents Working agreement Rules of Procedure and Mandates Products-related lists

Key achievem ents

Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Business processes I nform ation and Com m unication Tools

Reflection papers Good pharmaco- Vigilance Practice Guidance documents Questions and Answers documents Working agreement Rules of Procedure and Mandates Products-related lists Pharmacovigilance training

Key achievem ents

Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Business processes I nform ation and Com m unication Tools

Detailed Business Process Mapping

Key achievem ents

Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Business processes I nform ation and Com m unication Tools

Detailed Business Process Mapping Committees/ decision

• making

Key achievem ents

Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Business processes I nform ation and Com m unication Tools

Templates

Key achievem ents

Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Business processes I nform ation and Com m unication Tools

Templates Format for electronic submission of product information

Key achievem ents

Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Business processes I nform ation and Com m unication Tools

Templates Format for electronic submission of product information EMA Corporate website

19

EMA Corporate w ebsite

• Legal notice: EMA website will serve as the EU Medicines Web-

portal

• Upgrade of EMA corporate website

– New page for general public on pharmacovigilance implementation, including ‘video’. – Updated template for safety referrals – New search function for all referrals, – New page for industry on pharmacovigilance implementation

• Publication of plan for prioritised implementation

20

Prioritised im plem entation agreed by EMA Managem ent Board in Decem ber 2 0 1 1

21

Prioritised im plem entation agreed by EMA Managem ent Board in Decem ber 2 0 1 1

• Criteria for prioritisation:

– Firstly, public health activities – Secondly, transparency and communication activities – Thirdly, simplification activities (primarily for pharmaceutical industry)

• Activities grouped into four m ain topic areas:

– Collection of key information on medicines – Better analysis and understanding of data and information – Regulatory action to safeguard public health – Communication with stakeholders

• Traffic light:

Not started On-going im plem entation I m plem ented

22

I m plem entation of the pharm acovigilance legislation by the EMA in 2 0 1 2 :

Collection of key inform ation on m edicines ( 1 / 2 )

1 . Risk Managem ent Plans: Establishment and operation of new procedure for requesting and assessing RMP

• Started July 2012
• Templates for industry (Oct)
• Format compulsory (Jan 2013)

2 . Periodic Safety Update Reports: Operation of new procedures related to PSURs for CAPs

• Started July 2012

Development and publication of harmonised birthdates to support PSUR submission

• First list published in Oct 2012

(monthly update)

23

I m plem entation of the pharm acovigilance legislation by the EMA in 2 0 1 2 :

Collection of key inform ation on m edicines ( 2 / 2 )

3 . Post-Authorisation Safety and

Efficacy Studies: Implementation of the PASS procedure for protocols approval and results management for CAPs

• Started July 2012

Consultation on scientific guidance for PAES

• Awaited

4 . Electronic subm ission of core m edicine inform ation by MAHs ( ‘Article 5 7 ’) : Start validation of received information

• Joint implementation group

(Oct 2012) 5 . Reporting by patients: Cooperation with Member States to provide information to patients on direct reporting

• Core data fields agreed by

Member States (June 2012)

24

I m plem entation of the pharm acovigilance legislation by the EMA in 2 0 1 2 :

Better analysis/ understanding of data and inform ation ( 1 / 2 )

1 . EudraVigilance and signal detection Operation of revised signal detection process for CAPs

• Started July 2012

Support Member States to operate the new EU signal detection processes for NAPs

• Started July 2012
• Signal work-sharing list

published (Oct 2012) Start of signal management through the Pharmacovigilance and Risk Assessment Committee (PRAC)

• Started Sept 2012

Continuation of maintenance work for the current EV system including data quality

• As planned

Implementation of web-publishing of adverse reaction data (further to the EV Access Policy)

• Delivered in May 2012

25

I m plem entation of the pharm acovigilance legislation by the EMA in 2 0 1 2 :

Better analysis/ understanding of data and inform ation ( 2 / 2 )

2 . Additional m onitoring: Develop and publish the list of medicines with additional monitoring status

• Initial list likely to be published

in March/ April 2013 3 . I T system s to support processing and analysis of data: Finalisation of business requirements for enhanced IT systems

• On-going

26

I m plem entation of the pharm acovigilance legislation by the EMA in 2 0 1 2 :

Regulatory action to safeguard public health

1 . Scientific com m ittees and decision- m aking: Establishment of new committee (PRAC) and new responsibilities for CMD(h)

• Established July 2012

2 . Strengthening referral procedures: Operation of new referral procedure (Urgent Union Procedure)

• First referral launched

in Oct 2012

27

I m plem entation of the pharm acovigilance legislation by the EMA in 2 0 1 2 :

Com m unication w ith stakeholders

1 . Online publishing of inform ation:

Publication (on EMA website) of agendas, minutes, assessments, approvals, recommendations, opinions and decisions of PRAC, CMD(h) and CHMP .

• Started July 2012 for

PRAC agendas and minutes 2 . Coordination of safety m essages: Operation of the coordination of Member States’ safety announcements for non-CAPs.

• Started July 2012

3 . Public hearings: Introduction of public hearings in the context of Urgent Union Procedure

• Definition of public

hearings on-going

28

• New risk management process
• Periodic Safety Update Reports: list, centrally authorised product

(CAP) assessment, joint CAP and nationally authorised product (NAP) single assessment

• Safety studies: oversight of protocols and results for CAPs and NAPs
• Adverse reaction reports: collection, training, data management
• Signal detection and management for CAPs/ NAPs
• Committee: assessment and “decision-making”
• Publish adverse reaction data for CAPs
• New referral procedures
• Transparency: PRAC agendas and minutes
• Coordination of safety messages

W hat w ill continue in 2 0 1 3 ?

29

* Subject to agreement by EMA Management Board/ HMA:

• Legal proposal from the European Commission on fees for pharmacovigilance
• Several key scientific workshops to be held at the EMA (e.g. Medication error,

Efficacy studies)

• Maintenance, core validation and publication of structured product information
• Establishment of procedure for collaboration joint industry safety studies
• Publication of list of products under additional monitoring and introduction of

new ‘black symbol’ and specific statement in product information

• Public Hearings for Urgent Union Procedure
• Publication of CHMP and CMDh agendas and minutes for Pharmacovigilance

(further increase in transparency)

• Revised process for Pharmacovigilance inspections
• First EMA and National Competent Authority system audits

W hat is likely to be new in 2 0 1 3 * ?

30

• Further IT development: EudraVigilance (EV) functionalities, PSUR

repository

• EMA literature monitoring for adverse reactions and entry in EV
• Payments to rapporteurs
• PSUR single assessment for substances not included in CAPs
• Programme for monitoring effectiveness of risk minimisation
• Public hearings outside the scope of Urgent Union Procedures

Beyond 2 0 1 3 …?

31

Learning from implementation:

• Clarity of governance
• Careful impact analysis
• Strict planning and project management
• Detailed process mapping and process improvement/ simplification
• Dialogue and consultation with stakeholders (provisional booking for 2

Stakeholders fora in 2013 (June and September))

• Expectation management
• Focus on the key objective: promotion and protection of public health

Strengthen key success factors

32

• Prioritised implementation 2012 – on target
• Work on-going taking into new amendment to the 2010

legislation and remaining deliverables

• Funding (and staffing) remains the key risk to system

sustainability

• Journey is not over yet but we have a direction of travel: focus
• n promotion and protection of public health!

Conclusions

33

Thank you!