Risk Based Approach To Complaint Handling

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1 Risk Based Approach To Complaint Handling Khaudeja Bano, M.D. Senior Medical Director, Medical Device Safety Head, AbbVie Inc. Life Sciences Product Complaints Congress Europe Dublin, Ireland December 7-9, 2016

2 Agenda I. Complaint Management Process II. Quality Risk Management (QRM) Plan III. Risk-Based Approach to Complaint Management IV. Interactive Exercise 2

3 Complaints Complaint: Any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. Alleged deficiency - caution when determining what is and is not a complaint. It may be a good rule to treat any indication of dissatisfaction with a product as a complaint or product experience. Indirect sources - including reports and publications. (21 CFR ) 3

4 Complaints - Critical Components Process Procedures Personnel Proper Records 4

5 Complaint Management Process Monitor / Trend Intake Review Intake Review Evaluation / Assessment Investigation Report Closure Tracking and Trending Close Evaluate Report Investigate 5

6 Complaints Key Considerations Designate a formal complaint handling unit. Establish and maintain procedures for receiving, reviewing, and evaluating complaints Maintain complaint files All complaints processed in a uniform timely manner. Oral complaints need to be documented 6

7 Complaints Key Considerations Review and evaluate all complaints to determine if investigation is necessary No investigation - maintain a record that includes the reason and responsible role Determine reportability Prioritize reportable events Reportable events should be identifiable. 7

8 Complaints Investigation Identifiers related to the device and reported event If reportable: Reason Device failed to meet specifications Device was being used for treatment or diagnosis If applicable, the relationship of the device to the reported event Complaint files need to be reasonably accessible 8

9 Definition of Risk Management Systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling and monitoring risk (ISO 14971) 9

10 Risk Management Plan Assemble a cross-functional team responsible for the identification of the risk management activities Create the Risk Management Plan Review and approve the Risk Management Plan. 10

11 1. Purpose 2. Scope Risk Management Plan 3. Product Identification and description 4. Roles and responsibilities 5. Risk management activities to be performed including requirements and timelines 6. Risk acceptability criteria 7. Processes, Systems, Methods to gather relevant information for review and analysis of changes in risk or risk control effectiveness. 11

12 PRODUCT - Story Product Profile Class and more Risk Tolerance Always Reportable, Never reportable, case-by-case Expected Events Risk based rates Serious Injuries Malfunctions Quality issues annoyance Off-label use Unexpected behaviors 6 th Annual Pharmacovigilance, Drug Safety & Risk Management September 21 22, 2016 Philadelphia, PA 12

13 Risk-based Complaint Management Risk Management (RM) strategies to improve complaints Intake and Review Key (lot #), product specific Q s Evaluation / Assessment Preliminary risk-based decision trees Investigation Determine need and question to be answered, malfunctions, confirmation Report local, global and Others Closure complete story Tracking and Trending Feed into the RM Periodic review of the product to assess update of RM documents 13

14 Organizational Structure Teams Pharmacovigilance vs Complaint and Quality Single / Two or more teams Organizational Governance Research & Development / Quality Assurance Operations 14

15 Combination Product Post-Market Safety Reporting Drug / Biologic Device / Delivery system Combination product 15

16 Common Organizational Setup Two systems / Organizations / Different processes & procedures Common Recognition & intake process Evaluation Processing Investigation Reportability decision Reportability decision Trending Signal, Trending, Periodic Safety Reports 16

17 Drug / Biologic and Delivery System Constituent parts - Similarities All about safety & compliance Data gathering is critical What Both have reporting requirements Overlap of data Timelines Product lifecycle management Governance 17

18 Drug / Biologic and Delivery System Constituent parts - Differences Definitions & terminology Investigation for complaints Both have different reporting requirements System, timelines, nature (public health impact) Timelines are different Lead to label update vs product enhancement Coding SOC 27 / MedDRA Surveillance / tracking and trending 18

19 Drivers for Establishing Linkage Appropriate level of safety and compliance oversight Risk Management Product life cycle management Effective use of resources It adds up to safe use of product Benefit / risk holistic view Unified face to customer Enhanced data quality (Initial & follow-up) and compliance 19

20 Collaboration is Key Drug Safety + Quality Operations = Product Quality Improvement I. Product Design II. Risk Management III. Product Launch IV. Post Market 20

21 Collaboration is Key Drug Safety + Quality Operations = Product Quality Improvement I. Product Design Requirements Patient Population Clinical setting Interaction between components 21

22 Collaboration is Key Drug Safety + Quality Operations = Product Quality Improvement II. Risk Management Design it right the first time Design out risk Align on hazards / hazardous situation / harm and overall risk Focus on Risk where components interact 22

23 Collaboration is Key Drug Safety + Quality Operations = Product Quality Improvement III. Product Launch Product as a whole Constituent specific failures (Drug / Device) Interaction failures Label 23

24 Collaboration is Key Drug Safety + Quality Operations = Product Quality Improvement IV. Post Market Risk Model as reference Real world use Benefit Risk Equation 24

25 Risk Based model Remove redundant entry of data when possible Risk based decision evaluation vs investigation All AEs - safety evaluation Non AEs - safety oversight process Define system of record Automate reconciliation 25

26 Product as a System Drug Safety + Quality Operations = Product Quality Improvement Safety / Efficacy / Effectiveness Safety is the New Efficacy 26

27 Interactive Exercise Participants to develop a complaint process flow for common complaints expected to occur with a simple drug delivery system. Auto-injector or prefilled syringe with drug / biologic - Common complaints: - Serious Injury / Serious adverse events - Malfunction - Complaint - Risk - based complaint process (Discussion) 27

ISPE Annual Meeting 29 October 1 November 2017 San Diego, CA

ISPE Annual Meeting 29 October 1 November 2017 San Diego, CA Post Marketing Safety Reporting (PMSR) Challenges and Successful Practices for Combination Products Objective Session Goals Summary of the final rule Interpretation for combination products approved as