Pharmacovigilance PostJuly 2012 – The newfrontier

Colleen WalshHead, Safety and Benefit Risk Management Quality,

Biogen Idec

26th AnnualEuroMeeting

25-27 March 2014ACV, Vienna

Austria

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Agenda

• A Global Pharmacovigilance System – The Final Product Versus Getting There

• Goals of the Global System

• Success Factors

• A Biogen Idec Case Study

• Solutions (at least some)

Safety Headlines and Warning Letters

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EMA Slams xxx Over Extensive Safety Reporting 'Deficiencies'

FDA WARNING LETTER xxx

“The legislation is the biggest change to the regulation of human medicines in the European Union (EU) since 1995. It has significant implications for applicants and holders of EU marketing authorisations”.

EMA Website,http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000492.jsp&mid=WC0b01ac058033e8ad

A Global Pharmacovigilance System

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Global PV systemGlobal availability

of safety data

Soundsgreat!

A Global Pharmacovigilance System

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Robust and mature PV System and Processes

Getting there

Goals of Global PV System & New Legislation

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• Provide clear roles and responsibilities for all parties to enable robust and rapid decision-making

• Strengthen post-authorisation regulation

• Reduce duplication and improve efficiency

• Science based – integrate benefit and risk

• Increase transparency, harmonisation, and patient involvement

• IMPROVE OUR ABILITY TO ENSURE AND

ENHANCE PATIENT SAFETY!!

Success Factors for Implementation

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Communication

• Communication to concerned functional areas regarding legislation and associated ONGOING activities

• Reduction in duplicative efforts and streamlined decision making with all stakeholders “at the table”

Harmonization (to the extent possible)

Resources

• Not resource-neutral – human and technological resource requirements

• New PV Legislation means:

• increased dedicated office of the QPPV & Deputy QPPV

• increased reporting requirements

• increased PSUR and RMP requirements

• dedicated support of the PSMF and Pharmacovigilance Quality system

Success Factors for Implementation

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Safety

Clinical

Regulatory

Legal

IT

Affiliates and

Distributors

Quality Commercial

Quality

Biogen Idec July 2012

• Affiliates and distributors in multiple countries with widely different regulatory landscapes, processes and staff

• Fragmented understanding of local contract and vendor management practices

• Studies tracked (maybe) in multiple systems

• Different quality organisations responsible for audits

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Affiliates and Distributors• Safety Designated Staff but not “Safety people”

• Delegated/outsourced PV services in most circumstances

• Nature, location, and currency of contracts

• Resource and training model

• Process documents (local PV SOPs)

• Inspections and audits

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Affiliates and Distributors – Steps Taken

• Bi-annual affiliate and distributor meeting where PV information and PV legislative requirements are discussed/shared

• QPPV Monthly report completed by Safety Designated Staff at affiliates and distributors with key PV information – feeds into PSMF and may trigger update

• Data reviewed by central team and verification/follow-up conducted by Safety

• Affiliate training module for PV activities established, inclusive of relevant safety-related SOPs

• Affiliate – specific SOP detailing safety requirements

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Audits

• Multiple audit teams with multiple different Trackwise workflows

• No common methodology for documenting audit findings related to safety

• Understanding of which entities and vendors need auditing and application of a risk-based approach

• Expertise of auditing staff to conduct PV audits

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Audits – Steps Taken

• Establishment of PV Oversight Committee with attendance from all audit teams

• New Trackwise selections to allow common tracking and methodology for audit tracking related to PV

• Cross-training of audit staff on PV legislation and requirements; participation of Safety in audits

• Harmonization of audit categorizations and riskAssessment amongst groups

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Contracts and Studies

• Standard PV language not in contract templates or incorporated into contracts

• Management of new PV legislation requirements with corporate partners

• Vendor identification and qualification across Biogen Idec is not proceduralized

• How are ongoing studies tracked and in which systems?

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Contracts and Studies – Steps Taken

• Negotiated updates to Safety Data Exchange Agreements to ensure agreement that relevant sections of the PSMF will be shared and can be made available to a competent authority in the event of inspection

• Ongoing work with Commercial and Legal to standardize and implement contract language

• Increased collaboration on vendor selection and checklist for qualification

• Identification of systems of record for different study types

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Technology Can Help

• QPPV Dashboard with relevant feeds from systems

• PSMF is a sub-set of the data

• Cross-functional contribution

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Technology Can Help

• QPPV Dashboard with relevant feeds from systems

• PSMF is a sub-set of the data

• Cross-functional contribution

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Summary• Significant challenges still exist, but improvements have been made

• A global PV system is not static – it requires ongoing review and adjustment

• Technology can be your friend, if well-thought out and implemented correctly

“New pharmacovigilance legislation is a marathon, and not a sprint, for public health” - Dr Peter Arlett, Head, Pharmacovigilance and Risk Management, EMA

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