Risk Management Plan - Bayer Experience :

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1 Risk Management Plan - Bayer Experience : Organization & Processes Najoua ADYEL Pharmacovigilance Country Head Maghreb

2 Introduction: Pharmacovigilance toward maturity 50 s and 60 s: from nothing to reacting late 70 s : foundation of Pharmacovigilance principles 80 s to 90 s : From reacting late to reacting earlier 2000 Getting proactive and fast reacting Guideline on Risk Management Planning Proactive Risk Evaluation and Risk Mitigation measures Use of IT systems aimed at earlier detection of safety signals Use of large scale databases for signal detection Page 2

3 Pharmacovigilance nowadays Increasingly stringent heavy and complex Collection and evaluation of Individual Case Safety Reports (ICSRs) Wider array of source of safety information under scope Compilation of aggregate reports as (PSURs) Earlier detection and analysis of potential safety signals New Pharmacovigilance activities Proactive Risk Identification Proactive Risk Management plan Post-approval safety studies Proactive Risk Minimization measures Special Risk Mitigation measures whenever needed Timely update of the RMP upon detection of new signals Page 3

4 Bayer Global Pharmacovigilance: Organization with a global footprint > 500 FTEs worldwide (+ external FTE) > 70 sites 5 global centers + 1 outsourcing center Berlin Wuppertal Montville Beijing Mumbai Sao Paulo Page 4

5 Bayer Global Pharmacovigilance Partnering for Compliance Pharmacovigilance supports business success Proactive Risk Management Safety Communication Cross-functional partnering Trustful partner for HAs AE handling and compliance Page 5

6 Processes involved in Risk Management at Bayer Scheduled review of the accumulating safety information Evaluation of the outcome of computerized signal detection Scheduled delivery of Risk Management documents Structured process for the review of RM documents Safety Risk Management decision gate process Structured process for escalating safety observations and assess whether they constitute safety signals All processes apply during clinical development and afterwards, throughout the entire life cycle of the product All operated under Medical Governance Authority Page 6

7 Key Roles in RM Process at Bayer Page 7

8 Bayer Responsibilities at Local level: Regulatory Interact with Local HA regarding RM activities Adapt Safety RMP to Country requirements Prepare Country-specific RM document if required Prepare RMP for local products if required Decide whether the Safety RMP should be submitted if not formally required by regulation Address country-specific RM requirements and escalate them to the Global Safety Leader Page 8

9 Bayer Responsibilities at Local level: Implementation Verify whether safety interventions (e.g. risk mitigation measures) stipulated in the global Safety RMP are locally feasible; if not, alternative interventions should be defined Implement and supervise the execution of the safety interventions stipulated in the Safety RMP or the alternative interventions agreed upon with the Core SMT Implement safety interventions according to core RMP and/or according to alternative interventions defined. Provide feed-back to the Core SMT Page 9

10 Risk Management Plan in summary A set of Pharmacovigilance activities designed to: Identify, characterize, prevent, or minimize risks related to the medicine Assess the effectiveness of those interventions Communicate those risks to patients and health care providers Components of the RMP Detection of the risk Assessment of the risk Minimization of the risk Communication on the risk and risk minimizations measures Page 10

11 Safety Risk Management Activities Safety Risk Management activities have one of the following three major objectives: Increase knowledge Influence behavior on appropriate use of the product Restrict access to the product For each of these objectives there is a set of activities / tools that are generally appropriate to meet those objectives. Page 11

12 Risk Management guidance and tools according to the ICH Guidelines Aid planning PV activities in preparing early postmarketing period Focus on a Safety Specification and Pharmacovigilance Plan that might be submitted at the time of the MA application Describes a method for summarizing Important identified risks Important potential risks Important missing information including potentially at-risk populations/situations where the product is likely to be used that have not been studied prior to approval Proposes a structure for a Pharmacovigilance Plan and sets out principles of good practice for the design and conduct of observational studies. Page 12

13 Benefits expected from a Risk Management Plan Increase knowledge and raise awareness on: The safety profile of the product The sub-populations at risk who require more cautious use The proper way to use the product in patients at risk Influence behavior on appropriate use of the product: Ensure prescription in safe conditions Ensure cautious prescription and use in patients at risk Restrict access to the product Prevent the use of the drug in patients to whom risks would exceed benefits Page 13

14 Key terminology Risk mitigation: measure to minimize the impact of AEs which have occurred e.g. Pedicure care to patients experiencing drug-induced hand and foot skin reaction Risk minimization: measure to prevent the occurrence of an identified risk e.g. Ensuring that only patients with positive risk vs benefit receive the drug Special attention to patients at higher risk of occurrence of an AE to ensure early detection of the AE and timely intervention Risk management: broader term covering standard pharmacovigilance practice, risk assessment, risk minimization and risk mitigation measures Page 14

15 Routine risk minimization activities Routine risk minimization activities are those which apply to every medicinal product. These relate to: the summary of product characteristics; the labelling; the package leaflet; the pack size and design the legal (prescription) status of the product. The summary of product characteristics (SmPC) and the package leaflet are important tools for risk minimization as they constitute a controlled and standardized format for informing healthcare professionals and patients about the medicinal product. the design of the packaging, and even the formulation itself, may play an important role in preventing medication errors. Page 15

16 Additional risk minimization activities Those risk minimization measures which are not the routine risk minimization activities. They should only be suggested when essential for the safe and effective use of the medicinal product and these should be science based, and developed and provided by suitably qualified people. If additional risk minimization activities are proposed, these should be detailed and a justification of why they are needed provided. Any communication material should be clearly focused on the risk minimization goals, and should not be confused or combined with promotional material for marketing campaigns. Additional risk minimization measures can include: Educational programs Controlled access programs Other risk minimization measures Page 16

17 Methods for Risk Minimization If provision of information and education is sufficient to achieve risk reduction SmPC and Package Leaflet (routine risk management) Additional Educational Material (additional risk management) The need for additional material beyond the Summary of Product Characteristics and Package Leaflet depend upon the risk and should be considered case-by-case Otherwise, if provision of information/education is not sufficient to achieve risk reduction Legal Status of a Medicine Control at Pharmacy Level Control of Prescription Size or Validity Informed Consent and other Patient Aspects Restricted Access Programs Patient Registries Page 17

18 Risk Minimization Measures: Examples In addition to regular labeling (SmPC, Package insert) Box warning and special contraindication Additional information and educational measures Providing HCPs with specific training Providing HCPs with non-promotional education brochures/letter Medication guide/ Education brochure for patients Restriction measures Restricting prescription to certified physicians Restricting delivery to certified pharmacists Restricting dispensing the drug to specific specialized medical institutions Restricting dispensing only to patients with evidence of safety Page 18

19 Risk Minimization Measures: Examples cont d Special measures applying to patients Special patient monitoring Patient enrolled in registry Periodical monitoring laboratory tests Page 19

20 Effectiveness of risk minimization activities MAH are encouraged to discuss risk minimization activities with the competent authorities as early as is feasible when it is likely that specific risk minimization activities will need to be adapted to the different health care systems in place. For very complex risk minimization measures, it may be appropriate to contact competent authorities, in the countries where it is planned to market the product, either prior to submitting risk minimization proposals or during the course of the evaluation procedure. The need for a strong and dedicated structure for evaluating risk minimization activities The success of risk minimization activities in delivering these objectives needs to be evaluated throughout the lifecycle of a product to ensure that the burden of adverse reactions is minimized and hence the overall riskbenefit balance is optimized. Page 20

21 Conclusion The Safety Risk Management process is obviously one of the most complex processes with very far-reaching cross-functional involvement. Bayer Healthcare Safety Risk Management process takes this into account by alignment to already existing processes, involvement of cross-functional teams, and clear assignment of accountabilities and responsibilities. Page 21

22 Page

23 Thank you for your attention Questions are welcomed

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