Monitoring National Drug Safety

Medical devices Cosmetic products . National Regulatory Conference 2015 ... Monitoring Drug Safety in the Market Role of Industry Selangor...

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Monitoring Drug Safety in the Market Role of Industry

National Regulatory Conference Selangor Malaysia August 4-6, 2015

Dr J. Christophe Delumeau M.D. PhD. Head of Pharmacovigilance Asia-Pacific & China Bayer South East Asia (Singapore).

Disclaimer: The views and opinions expressed in the following slides are those of the individual presenter and should not be attributed to the Organizers of this meeting, nor to any legal entity belonging to the Bayer group. National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

J.C. Delumeau

Slide 1

Drug Safety toward Pharmacovigilance Definition and Scope  WHO definition (2002): The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.  Pharmacoepidemiology under the scope of Pharmacovigilance  Broad Scope of Pharmacovigilance  Pharmaceuticals: Prescription and Over The Counter (OTC)  Biological products e.g. vaccines, recombinant, biosimilar etc..  Herbal and other traditional medicines  Medical devices  Cosmetic products

National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

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Slide 2

Pharmacovigilance Stakeholders  Patients/Users increasingly empowered sharing individual experience in a pair to pair manner on the Internet  Health Care Professionals (HCPs)  Prescribe the products. Responsible for individual patients

 Health Authorities  Approve products. Responsible for public health  Health Care Industry  Need to innovate to sustain profits, otherwise disappear  Media who, in addition to their mission to inform, may trigger media issues to increase their visibility and audience.

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Slide 3

Pharmacovigilance in the Industry Partnering Internally and Externally  Partnering across functions and with external stakeholder is critical for Industry’s PV departments. 

Regulatory affairs: Safety communication with Health Authorities



Clinical Operations: Interventional studies



Medical Affairs: Non-interventional studies, Medical Information



Commercial functions: in contact with Prescribers



Corporate Communication: dealing with media



Health Authorities: Adverse Events submission, Legislations



Academic Experts: Investigators, Data Monitoring Safety Boards



Contract Research Organisations: Multiple types of investigations

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Within License Holder’s Organisation

J.C. Delumeau

External

Slide 4

Pharmacovigilance in the industry The 3 pillars of a broad scope activity Goal: Maximise the benefit of medicinal products versus the risks, by ensuring the proper use in the approved indications, and minimising the risk of occurrence and impact of untoward effects.

Single Case Management

Safety Management

National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

Governance & Oversight

J.C. Delumeau

Slide 5

Single Case Management

Single Case Management

Safety Management

National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

Governance and Oversight

J.C. Delumeau

Slide 6

Single Case Management Guidelines and Legislations  CIOMS Group I on International Reporting of Adverse Drug Reactions released the CIOMS-1 Report and the CIOMS-1 Form in 1990.  This work served as basis for the ICH-E2A guideline on Definitions and Standards for Expedited Reporting and ICH E2B guideline on Electronic submission of ICSRs.  Those ICH Guidelines were implemented into the Legislations of ICH Countries i.e. USA, EU, Japan, Canada and Switzerland.

 An increasing number of non-ICH countries are progressively aligning their submission requirements with the above guideline. However, complete global harmonization is not achieved.  Increased stringency resulting from EU-GVP (2012)

National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

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Slide 7

Collecting Adverse Events The fuel of Pharmacovigilance activities Definition of an Adverse Event: Any undesirable occurrence in a patient or subject receiving a medicinal product, which occurrence does not necessarily implies a causal relationship to the product administered.

   

At least one Adverse Event For an identifiable medicinal product In an identifiable patient Reported by an identifiable person

National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

Individual Case Safety Report (ICSR)

J.C. Delumeau

Slide 8

ICSR basic Criteria How to understand identifiable?

At least one Adverse Event: Not necessarily a medical term. May be a lay expression reported by the Patient or Consumer

Identifiable Product: Awareness of the non-proprietary name is enough even if unsure it is a Company product. Details on the formulation and dosage are not required for considering the product identifiable.

Identifiable Patient: Awareness of initials or gender, or age is enough to consider the patient identifiable.

Identifiable Reporter: Information such as “reported by the consumer

himself” or “a relative of the patient”, or “the treating physician of the patient” or “the pharmacist who delivered the product” is enough to consider the Reporter as identifiable.

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Slide 9

ICSR data collection Content of CIOMS-1 Form       

Patient initials Country of reporting Date of birth / age Gender Reaction onset date Seriousness criteria Narrative description of the event

     

Suspect drug Daily dose. Route of administration Indication for use Therapy dates and duration If AE abated or not after stopping drug? If AE reappeared or not after re-introduction?

 

Concomitant drugs. Date of administration Other relevant medical history

   

Identification of the Product License Holder Source of report: study/HCP/HA/Literature Date the report was received Report submission date. Initial/Follow-up National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

J.C. Delumeau

Slide 10

Extended ICSR Scope Should be handled as ICRS  Exposure of a pregnant women  Exposure of the male responsible for pregnancy  Lack of drug effect  Overdose  Misuse  Medication error  Off-label use  Occupational exposure  Product Technical Complaints

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Slide 11

ICSR Handling Process Reporting Timelines for post-marketing reports  Early notification of Deaths: within 1 day (China, Thailand)  7-day AE Report: Deaths or life-threatening events

 15-day AE Reports: Other Serious Events  30-day AE Reports: Non-serious Event (for spontaneous reports) According to ICH timelines

Most Counties but not all, accept ICH timelines for ICSR submission Most non-ICH countries request only Domestic ICSRs National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

J.C. Delumeau

Slide 12

ICSR Handling Process Product Technical Complaints (PTC)  Product defect classified based upon the nature of the complaint and the potential risk to consumer safety  Category I: Defect potentially life-threatening or could cause serious risk

 Category II: Defect could cause illness or mistreatment but not category I  Category III: Defect may not pose a significant hazard to health

 Category IV: Defect does not pose a hazard to health  Category V: Non-defective product

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Slide 13

ICSR Handling Process Incidents reported with Medical Devices  EU’s MEDDEV serving as reference in an increasing number of countries  Also reported as Product Technical Complaints (PTC)  Product not necessarily defective  2-day Incident Reports: Serious Public Health Threat  10-day Incident Reports: Serious Event actually occurred

Meeting MEDDEV definition of Incidents

 30-day Incident Reports: PTC which may have caused a Serious Event

 Non-Incident: PTC associated with a non-serious Event  Non-Incident: PTC not associated with any event National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

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Slide 14

Single Case Management ICSR Intake and Data Entry  Triage, duplicate check  Case documentation Risk Management

 Translation of source documents

Activities

 Primary data Entry into safety DB  Solicited vs Non-solicited

Single case evaluation Single case processing Single cases data entry Intake of ICSR

Solicited:  Interventional and non-interventional studies  Patient Support Programs  Market Research and Active Online listening  Company-sponsored social media  Product hotlines Non-solicited:  Spontaneous  Literature

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Slide 15

Single Case Management Processing ICSRs  Processing: information is further structured according to standard rules. Risk Management Activities

Single case evaluation Single cases processing

 Listedness is established referring to CCDS or Country labeling  Seriousness is checked. Upgrading to serious may be decided

 Follow-up information may be requested as a query sent to the reporter.

Single case data entry Intake of ICSR National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

J.C. Delumeau

Slide 16

Single Case Management Evaluating ICSRs

 Seriousness is confirmed

Risk Management Activities

Single cases Evaluation Single case processing Single case data entry

 Determination of the causal relationship between the suspected product and the reported event.  Usually performed by a Medical Doctor centrally  Country-specific evaluation may be required e.g. Japan, China, France

Intake of ICSR National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

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Slide 17

Evaluating ICSR Key terminology

 Seriousness  Causality

 Adverse Event (AE) vs Adverse Drug Reaction (ADR)  Suspected Unexpected Serious ADR (SUSAR)

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Slide 18

Evaluating ICSR Seriousness  Seriousness differs from Severity  Serious AE has a safety regulatory definition: AE meeting at least one of the following:  Leads to death  Life threatening  Requires hospitalization/prolongation of hospitalization

 Results in persistent or significant disability  Congenital abnormality or birth defect  “Medically Important” is a more subjective concept

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Slide 19

Evaluating ICSR Seriousness Medically Important  Reporter considers it serious  AE term included into a list of terms Medically Important by definition e.g. WHO list, EMA list, Company-specific list.  The Company may decide to upgrade to Serious e.g. in consideration of the severity of the symptoms.

Remark: Because regulatory submission timelines depend upon the Seriousness, it is safer, in case of doubt, to upgrade the case to Serious in order to ensure case processing according to shorter timelines. Subsequent downgrading (after upgrading) may be possible if justified.

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Slide 20

Evaluating ICSR Causality

 Adverse event: Any untoward/undesirable occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily need to have a causal relationship to this treatment.  Adverse Drug Reaction: A response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility.

National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

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Slide 21

Evaluating ICSR Causality Remarks: Different countries may apply different causality categories:  Definite/Probable/Possible/Unlikely/Not related/Non assessable  Can/Cannot be denied (with a low threshold in Japan)  Imputability method (France)  Remark: Causally Associated Yes/No, based upon “at least a reasonable possibility” is the most practical causality assessment method for decision making in clinical trials (e.g. code breaking) and for the management of large amounts of safety data. However, this can hardly reflect complex safety observations.

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Slide 22

Evaluating ICSR Causality

Important remarks:  The Reporter and the Company may apply a different Causality assessment for an individual case. Then: 

The divergence of opinion shall be made very transparent in the ICSR submitted to Health Authorities

 Overall, the most conservative causality assessment shall prevail i 

Serious shall prevail versus Non-Serious



Causally related shall prevail versus Non-related

National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

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Slide 23

Evaluating ICSR Suspected Unexpected Serious Adverse drug Reactions  SUSARs: Causally-related and Unlisted (unexpected) ICSRs  Constitute new serious safety information: Expecially under scope  Should be reported to Investigators and Ethics Committees of clinical trials  Should be reported blinded or un-blinded depending upon Country / Ethics Committee requirements

Major harmonisation issue  Rules applicable for submitting SUSAR to Investigators and Ethics Committee, vary depending upon Countries, from a expedited reporting, to summary listing, every 3 to 6 months.

National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

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Slide 24

Safety Management

Single Case Management

Safety Management

National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

Governance & Oversight

J.C. Delumeau

Slide 25

Safety Management overview Activities beyond Single Case Management

Risk minimisation decision Signal confirmation

 Considering further inquiry

Signal evaluation

 Based upon medical judgment.

Signal detection

 Computerised algorithms in addition standard methods

Single case evaluation Single case Processing Single case data entry

 Consistently reflected in Risk Management Documents  PSUR/PBRER  Benefit/Risk Statement

Intake of ICSR National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

 Risk Management Plan

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Slide 26

Safety Management overview Risk Management decisions

Risk minimisation decision

 Following processed under strict medical governance

Signal confirmation Signal evaluation Signal detection

 Change in the CCDS of the product

 Change in the content of the RMP  Risk Minimisation decision

Single case evaluation Single case Processing Single case data entry Intake of ICSR National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

J.C. Delumeau

Slide 27

Safety Management overview Cycles of Risk management Activities

Risk minimisation decision Signal confirmation Signal evaluation Signal detection Single case evaluation Single case processing Single cases data entry Intake of ICSR National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

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Slide 28

Safety Management overview Cycles of Risk management Activities Determine safety profile

Update safety profile if necessary

Evaluate the benefit versus risk

Re-evaluate benefit versus risk

Design safety communication and risk minimisation

Update Safety Communication. If needed, design and implement complementary risk minimisation

Post-Authorisation: Implement risk minimisation plan. Collect and evaluate adverse events

Continuously collect and evaluate adverse events

Screen and Evaluate signals from databases

Continuously screen and Evaluate signals from databases

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Slide 29

Safety Management Overview Cycles of Risk management Activities

How to achieve it?     

Regulatory framework Methodology Resources Processed Governance

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Slide 30

EU-GVP Module V Risk Management Systems

 2004 / 2005: the ICH-E2E guideline implemented in the EU, USA and Japan PV regulations.  2012: EU-GVP Module V: Risk management systems  New EU-RMP Template more complex than in Volume 9A  A revision of the EU-RMP template is under discussion.

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Slide 31

ICH-E2E & EU-GVP Module V Part II Safety specification

Key concepts of the ICH-E2E Guideline:

 “Safety risk” is the Probability of harming as an outcome of product intake  Level of Risk = Probability of harming X Severity

variable that refers to the frequency of an event

National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

variable that refers to the medical impact of the event

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Slide 32

ICH-E2E & EU-GVP Module V Part II Safety specification  Identified Risk  Adequate evidence of an association with the product of interest

 Potential Risk  Some basis to suspect an association with the product. However, the association is not yes considered as confirmed

 Important Risk  Depends upon the seriousness in consideration of the impact on individuals and/or public health  Remark: Risks referred to in the contraindications or warnings and precautions sections of the CCDS are usually categorised Important Risks. National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

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Slide 33

ICH-E2E & EU-GVP Module V Part II Safety specification  Important identified risk  e.g. abnormal liver function test observed during clinical development suggesting a risk of hepatic impact

 Important potential risks  e.g. no clinical evidence in human so far but histological findings in an organ in one animal species. Or chemical structure has some similarities with a drug known to impact an organ

 Important missing information  e.g. no experience in a category of patients or medical situation in whom the product may be used after launch.

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Slide 34

Safety Management Core Safety Management Teams

 Chaired by a Global Safety Leader (GSL)  Product-wise multi-disciplinary team of internal experts  Responsible throughout the life cycle of the product for ensuring that the benefit versus risks remain positive, otherwise the GSL shall escalate the concern to the next governance level.  GSL responsible for Risk Management deliverables throughout the whole life cycle of the product (next slide)

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Slide 35

Safety Management Safety Management Documents  Safety input into the Project Master Plan  Benefit-Risk Summary (BRS): scientific evaluation of risk benefit balance and summaries of data relevant to benefits and risks.

 Benefit Risk Profile (BRP) concise document with bullets for each benefit, risk, and risk minimization actions.

 Periodic Safety Update Reports (DSUR and PSUR) following the ICH E2C (R2) Periodic Benefit Risk Evaluation reports (PBRER) format

 Risk Management Plan (RMP)  Development RMP (until Phase III)    

Core RMP (after Phase III throughout life cycle, reflecting Company position) EU-RMP at initial submission to the EMA EU-RMP resulting in EMA approval Local RMPs and REMS in non-EU countries

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Slide 36

Safety Management Benefit vs Risk Assessment (RMP and PBRER)  Comprehensive, concise and critical analysis of the Benefit vs Risk (B/R) balance of the medicinal product  Incorporating an evaluation of the safety, efficacy and effectiveness information that becomes available (Basis for evaluating B/R balance)

 The Risk evaluation should cover all uses of the product including nonapproved indications and other uses.  The B/R balance should be evaluated for each indication individually and for each of the populations susceptible of receiving the product. Remarks The strengths, weaknesses, and uncertainties of the evidence used in the B/R evaluation should be discussed. National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

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Safety Management Local Safety Management Team Chaired by the Country Pharmacovigilance Head

 Membership    

Country Medical Director Country Pharmacovigilance Head (Lead) Local Regulatory Affairs Head Representatives from other functions as required

 Responsible for

 Adapting the RMP to Country requirements

 Preparing Country-specific RM documents  Addressing country-specific RM requirements  Escalating requests from HA to the Global Safety Leader  Supervising locally the execution of risk minimization commitments National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

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Slide 38

Safety Management Processes under Medical Governance

 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  Structured escalation of Safety Observations and Signals  Structured safety decision making process  All processes apply during clinical development and afterwards, throughout the entire life cycle of the product

 All operated under Medical Governance authority National Regulatory Conference 2015 Selangor Malaysia 2015.08.04

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Slide 39

Safety Management Escalation of Safety Observations

 Structured process for escalating safety observations and assess whether they constitute safety signals  Safety Decision & Medical Governance Committee  Safety Review Committee  Global Safety Leader / Therapeutic Area Safety Head  Regional PV head / Global Safety Leader  Country Pharmacovigilance Head/ Drug Safety Officers

 More details in the following section (Medical Governance)

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Slide 40

Safety Management Monitoring Risk Management Commitments

 Risk management commitments are monitored by a dedicated function belonging to Risk Management.  Ensuring that risk minimization commitment are:    

Adequately justified (e.g. by Country HA request) Approved by the relevant global medical governance committee Actually and properly implemented and executed and that risk minimisation activities are properly recorded

 Global scope because not only EMA and US-FDA may request additional risk minimisation.

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Slide 41

Governance & Oversight

Single Case Management

Safety Management

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Governance & Oversight

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Slide 42

Governance Escalation to Safety Governance Boards

Global Safety Committee Endorse/reject/amend/complement RMPs, Risk Minimization decisions, labeling changes, responses to questions/requests from HAs

Safety Review Committee Confirm/deny signals or request further investigations

Review risk management items to be escalated to above Committee

Local Safety observation

Suspicion of signal by RM

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Suspicion of signal by HA

J.C. Delumeau

Slide 43

Governance Safety Review Committee

 Meet several times a month  First instance safety board in the escalation process

 Receive and evaluate safety observations  Request investigations to clarify safety observations  Evaluate whether a safety observation should be considered as a safety signal and escalated to the Safety Decision & Medical Governance Committee.

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Slide 44

Governance Global Safety Committee

 Meet at least once a month  Endorses Benefit Risk Statements

 Provide mandatory input at the clinical development milestones  Endorse/challenge decisions escalated from the SRC  Approve safety objectives and interventions  Recommended risk management/minimisation actions  Supervise the implementation of Risk Minimization measures

 Supervise the execution of the processes under Medical Governance

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Slide 45

Oversight Training on ICSR Reporting obligations

 Any Company employee, has the obligation to report in a timely manner (24h) to the PV department of the Company, any AE associated to the use of a Company product which she/he may become aware of, including in non-professional circumstances.  Applies also to external business partners (e.g. CRO), or contractors (e.g. Academic experts or nurses) during their contractual activity for the Company.

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Slide 46

Oversight Contactual Agreements

 Pharmacovigilance language embedded into Main Contractual Agreements.  Separate Pharmacovigilance Agreements referred to in the Main Agreement  Ensuring that any Medical or Commercial activity involving Patients administered any Company product is under scope

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Slide 47

Oversight Diverse source of Safety Information  Health care professionals (HCPs)

 Consumers, Patients, Communities, Associations, Lawyers  National public health system / Health Authorities  Interventional and non-interventional clinical studies  Investigators-sponsored studies  Numerous types of non-interventional programs  Market research investigations  Medical and scientific literature

 Product-dedicated hotlines or social media  Data mining investigations  Collection of real life evidence data  New sources to be invented…

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Slide 48

Oversight Non-Interventional Programs  Early Post-Marketing Vigilance Phases (Japan)  Post Marketing Vigilance Program (Indonesia)  Patients Support and Disease Management Programs (PSDMPs)  Market Research Studies  Compensation and Reimbursement Schemes  Any collection of product use information at the patient level

Important Remarks  Any collection of information at the individual patient level may expose to the awareness of information qualifying for an ICSR

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Slide 49

Oversight Social Media  Company-sponsored Websites, Facebook pages, Twitter etc..

 Health Authority websites giving access to ICSR information  Are non Company-sponsored social media under scope?  Screening the myriad of non Company-sponsored social media is hardly possible. No regulatory obligation to screen them so far  Search engines are being developed to detect ICSRs from the whole Internet possibly detecting amounts of information which can hardly be inquired and medically confirmed.

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Slide 50

Oversight Global Trends in Safety Communication  ICH and non-ICH Health Authorities make available on the internet an increasing amount of information relative to the safety of medicinal products, including:    

Anonymised ICSRs Graphs of compiled post-marketing safety information Suspicion and confirmation of safety signals Description of risk minimisation activities.

 Health Authorities interact with each other increasingly across borders  Pharmacovigilance is performed in a context of global transparency and fast communication.

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Slide 51

Concluding Remarks  Pharmacovigilance nowadays is the result of 50 years of evolution toward:



More sophisticated PV systems



More stringent legislations



Earlier detection of safety signals



Implementation of additional risk minimisation



More transparent risk communication

 No longer limited to ICH regions this evolution is spreading globally including in developing countries.  Further evolution is anticipated as consumers and patients accessing information instantly from anywhere, are getting increasingly sensitised about safety matters, empowered and demanding.

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Slide 52

Monitoring Drug Safety in the Market Role of Industry

National Regulatory Conference Selangor Malaysia August 4-6, 2015

Thank you for your attention

Disclaimer: The views and opinions expressed in the presented slides are those of the individual presenter and should not be attributed to the Organizers of this meeting,National nor to Regulatory any legalConference entity belonging to the Bayer group. 2015 Selangor Malaysia 2015.08.04

J.C. Delumeau

Slide 53