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Chris Holmes Principal, WCI Consulting Ltd

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1 Chris Holmes Principal, WCI Consulting Ltd
Pharmacovigilance and Drug Safety: Top 10 Issues facing Compliance and Legal Pharmaceutical Regulatory Compliance Congress and Best Practices Forum November 8th 2007 Washington DC Chris Holmes Principal, WCI Consulting Ltd

2 Contents Pharmacovigilance (PV) environment Best Practices Forum
Top 10 issues Current industry responses Conclusions

3 Pharmacovigilance environment
Move beyond compliance to proactive, medically driven safety risk management Constantly evolving regulatory environment with increased enforcement Increased interest in drug safety by stakeholders, desire for more transparency Increasing workload

4 Industry response to current environment
Existing Future

5 An Industry Forum has benchmarked current practices and developed future practices
12 large pharmaceutical and biotechnology companies, since 2001 Heads of Pharmacovigilance 26 medium sized companies, inc. Rx, OTC, Devices, Generics 12 large and medium pharmaceutical companies In-house lawyers

6 *Source: pvnet Members, not prioritized
Top 10 PV Issues* QP-PV role and responsibilities Contractual arrangements Governance & Quality Management System Increased enforcement of Regulations Formalised Signal Management process Submission of Risk Management Plans (RMPs) Developing RMPs across product lifecycle Aligning PV organisation to enable proactive safety Individual reporting of ICSRs Maintaining efficient PV process *Source: pvnet Members, not prioritized

7 1. QP-PV role and responsibilities Clarified in EU Volume 9a, January 2007
Establish/maintain/manage MAH PV system Overview of safety profiles, emerging safety concerns Single contact point for Authorities Ensure execution of PV obligations: collection of ADRs at one point in the EU preparation of reports e.g. PSUR, PASS continuous post-authorization PV evaluation Ensure that requests from Authorities are answered fully & promptly

8 1. QP-PV role and responsibilities Industry Responsibilities have been clarified in Vol. 9a
Provide overview of, and direct access to, information regarding safety profiles, emerging safety concerns Ensure adequate representation in medical governance Assign sufficient authority to actively manage PV system Develop Performance Mgt to support safety objectives Increase employee awareness of safety responsibilities, ensure effective mechanisms in place to enable issues to be captured

9 2. Contractual arrangements
MAH must have “detailed and clear documented contractual arrangements” in place MAH must provide authorities with “information on such arrangements” Closer collaboration with legal and commercial functions required for compliance Defined process for early involvement of PV in portfolio decisions and due diligence

10 3. Governance & Quality Management System
Detailed Description of Pharmacovigilance System (DDPS) required for submissions in EU More transparency of how MAH PV system works Template based on Volume 9a expectations Emerging good practice, key document for Inspections Need to align and simplify SOPs across PV and operating companies Create ‘PV Handbook’ for inspection readiness in all affiliates Establish Operational Risk Management framework Proactive, systematic approach to identifying and mitigating compliance risks

11 3. Single global Quality Management System Operations & Compliance framework
Failure , Effect, Cause, Risk index People Process Technology Governance Structure F E C R

12 4. Increased enforcement of Regulations
Recent shift towards stricter enforcement of stricter EU rules EU inspections becoming routine Each Member State responsible for inspections Need for clear and consistent inspection standards Need to keep abreast of ‘Hot Topics’ as inspection standards and focus varies New EU Penalties legislation (July, 2007) Applies to centrally authorized products Financial penalties to MAHs in respect of infringements Financial risk associated with non-compliance: up to 5% of total EU annual turnover per annum

13 5. Formalised signal management processes
Signal Management becoming more proactive and formalised pvnet benchmark data shows maturing approach pvconnect Nothing formal beyond PSUR / ASR reports Limited signal detection SOPs Use of some ad hoc reports primarily looking at AE counts and frequencies Consistent local SD SOPs Use of regulatory methodologies (e.g., EBGM) and thresholds Use of external data sources for background values Global SD SOPs Use of modeling tools to explore “what-if” scenarios Electronic tracking of signal life-cycle from detection to resolution SD processes integrated with risk mgt plans Full data warehouse incorporating cross-organizational data (e.g., marketing, etc.) Thought leader in SD approaches & methodologies Established communication plan between stakeholders 1 - Basic 2 3 4 5 - Mature pvnet

14 5. Formalised signal management processes Benchmark findings
pvconnect pvnet Have SOPs describing signal detection and evaluation processes 73% (11/15) 93% (13/14) Treat inquiries from regulatory agencies/DSMBs as signal sources (8/11) 86% (12/14) Specify timelines to ensure timely evaluation of signals 46% (5/11) 50% (7/14) Document actions taken for signals that progress to further evaluation 80% (12/15) 79% (11/14) Document actions taken for signals that do not progress to further evaluation 29% (4/14) Have signal detection processes integrated into risk management plans 13% (2/15) 36% (5/14)

15 5. Formalised signal management processes Industry responses
Signal detection SOPs integrated into Safety Risk Management processes Consistent responsibilities and accountability for signal detection and management, especially between pre- and post-marketing Benefit-risk evaluation procedures documented and clear accountability determined Vol 9a: “The MAH shall forthwith inform the authorities of any other new information which might influence the evaluation of benefits and risks of the medicinal product concerned” Industry suggestion: decision tree based on public health impact Perform proactive internal audits (Regulators are auditing signal detection processes)

16 6. Submission of Risk Management Plans
Obligation to submit an EU-Risk Management Plan (RMP) Application for a new MA (new active substance) Application for significant change in a MA (new dosage form) On request of Competent Authority (pre- and post authorization) On initiative of Applicant/MAH (when “safety concern” identified) EU and US requirements similar in practical application companies tending to be driven by EU requirements as US is currently less onerous Monitoring is key* 83% of RMPs have proposed studies, only 9% reliant on standard PV alone (with no proposal for additional studies or other actions) Of the proposed studies, a third had not provided an update where one was expected and additional third had not yet started the studies MHRA and EMEA considering enforcement mechanisms * source: MHRA (ISoP Annual Conference Oct 2007)

17 7. Development of lifecycle Safety Risk Management
Drive towards more proactive, systematic approach to identifying potential safety concerns FDAAA grants FDA sweeping new authority to require: Post-marketing studies and clinical trials Safety labeling changes Risk evaluation and mitigation strategies (REMS) Companies are formalising risk management activities earlier in the product lifecycle (pvnet) PV is generally accountable for safety risk management activity

18 The development of RMPs is currently largely driven by regulatory needs in EU Source: pvnet survey
Only 1 company has a finalised SOP for RMP development, though 4 more have them in draft Responsibility for monitoring implementation and effectiveness is PV in 4 companies and a mix of functions in others e.g. clinical

19 7. Development of lifecycle Safety Risk Mgt Industry responses
Define risk mgt approach from First-In-Man or earlier and throughout lifecycle: Formalise processes and tools Implement Safety Management Teams for Clinical Development Projects (see CIOMS VI) Define responsibilities for risk identification, mitigation, monitoring of implementation and effectiveness Ensure consistent global communication on medical safety risks Ensure a single safety risk management plan exists for all development and key marketed products

20 8. Aligning PV organisation to enable proactive safety
Increase employee awareness of safety responsibilities Training Curricula & toolbox for all employees Attract and retain high quality competent resources Improved recruitment & assessment process Career Path alignment with key functions e.g. Clinical Improved capability e.g. safety risk mgt, epidemiology PV competency framework Balance workload requirements and maintain compliance Define and implement new roles with clear responsibilities Implement capacity planning process

21 9. Expedited Reporting of Individual Case Safety Reports
Clock for expedited reporting: starts “Day 0” as soon as the minimum information has been received by: Any personnel of the MAH or Any organization having a contractual arrangement with the MAH, including CROs, marketing partners, medical representatives etc Partner agreements impacted and will need reviewing to ensure that they meet new standards Impact on process metrics and other compliance measures

22 10. Maintain efficient PV process
Efficient routine PV process are required to manage growing scope and volume of data pvnet: avg 10% increase in ADR volume for last 7 years pvnet data shows increase in productivity, data quality compliance and increased investment in proactive safety surveillance pvnet: 2005 v 2006 (12 of Top 25 Pharmacos) 10% increase in productivity 30% increase in ‘Scientists’ effort on routine PV, corresponding reduction in Physician and Data Processor effort. 15% increase in signals generated by internal process (rather than notified by external agencies)

23 10. Maintain efficient PV process
Simplify global routine PV processes Align global roles and responsibilities, strengthen links with affiliates Harmonise product International Birth Dates to streamline PSUR processes Improve automation Automate ADR data entry (e.g. call centre, key affiliates) Run automatic quantitative analysis for signals Automatic PSUR compilation

24 Imperatives Understand all potential compliance exposures as inter-related View Drug Safety, Medical Affairs, and Quality Operations exposure from an integrated perspective Align approach to policies, QMS, training and audits Review global infrastructure for PV and partner functions Ensure in-house legal counsel support to PV

25 Thank you Chris Holmes WCI Consulting Ltd

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