Transcript beacham_6

Best Corporate Practices in Meeting
the FDA’s Safety Reporting
Requirements
FDA Regulatory and Compliance Symposium
Presenter: Saundra Beacham, Director, Drug Safety Operations
Actelion Pharmaceuticals US, Inc.
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Presentation Objectives
Addressing the corporate practices for meeting FDAs Safety Reporting
Requirements in the following areas:

Standard Operating Procedures (SOPs) & Guidelines

Training Program

Assessment / Triage of Adverse Events

Evaluation of Labeling

Post-marketing Commitments

Lessons from Regulatory Inspections
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Standard Operating Procedures (SOPs) &
Guidelines
Development of SOPs & Guidelines or Working Instructions

SOPs – broader in scope

Guidelines & Working Instructions – step by step details
 Ensure
 Set
that SOPs are consistent with the regulations
realistic expectations
 Train
colleagues
 Ensure
SOPs / Guidelines reflect work practices
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Standard Operating Procedures (SOPs) &
Guidelines, cont.
Periodically review SOPs, update as needed
 Revise
 Have
SOP before implementing changes
a system in place for revising SOPs
 Remove
reference for inactive documents
 When
more frequent review is not needed, SOPs and
guidelines should be reviewed on an annual basis.
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Training Program
 Develop
a Training Program
 Training
of Colleagues in Department
 Permanent
 CFR,
and Contract colleagues
ICH Guidelines
 Standard
Operating Procedures
 Guidelines
/ Working Instructions
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Training Program

Training of Colleagues in Other Departments

New company employees



Overview of Drug Safety Department and AE reporting
Sales and Marketing colleagues

Procedures designed for Sales colleagues for reporting AE
information

AE Collection Form available on company intranet
Distributors

Interface with distributors, provide instructions & form(s) for reporting
adverse experience information to company
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Assessment of Adverse Events
Individual case assessment by Medical Reviewer
 Case
review of all adverse events upon receipt of
information in department.
 Evaluation
of information from the reporter and company
perspectives:

Seriousness criteria

Labeling

Causality / Relationship

Comments and recommendations for follow-up
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Assessment of Adverse Events
Group assessment by Global Drug Safety (GDS) representatives
 GDS
representatives meet weekly for case review
(physician input required).
 Each
Drug Safety unit identifies:

Potential expedited cases

Other cases of interest
 GDS
representatives discuss cases in meeting and make
final decisions regarding reporting to which countries and
regulatory agencies.
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Evaluation of Labeling
Determine whether the adverse event is labeled or listed in the
labeling documents
 An
event is unlabeled when the event term is more specific
or more severe than what’s indicated in the label.
 When
an event is associated with a patient death, then the
event is unlabeled unless the labeling document indicates
fatalities are associated with the event.
 An
event is unlabeled when its only reference is in class
labeling.
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Evaluation of Labeling
Create Labeling Conventions to assist in determination of labeling. Here
are a few examples, document:

Interpretations in labeling, e.g.

Anemia is labeled, yet anemia w/blood transfusion is not labeled.

Weight gain is labeled, but weight gain greater than 20% is not
labeled.

How Lack of Efficacy will be handled

How labeling will be handled when drug use is off-label.
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Evaluation of Labeling
 Those
terms that are included in association with indication
for drug.
 Any
labeling issues that are part of the post-marketing
commitment.
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Post-marketing Commitments


Meeting additional regulatory
obligations associated with drug
approval may include:

Expediting abnormal liver
function events

Expediting all pregnancies
Holding periodic meetings with
medical experts
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Lessons from Regulatory Inspections

Document correspondence from meetings regarding adverse events.

Have a system of tracking all incoming events and source information
from receipt at company to submission.

Track expedited reports. When reports are late, provide a reason for
late submissions.

Have a procedure in place for determining when a case should be
closed

Be prepared to produce safety training records for all company
employees who are likely to hear of AEs (e.g. Supply Chain Mgmt)
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Lessons from Regulatory Inspections
 Have
written procedures for handling adverse events / product
complaints.
contractual agreements with distributors and/or 3rd parties
for collecting and reporting adverse events.
 Have
 Be
able to readily tabulate different types of event categories by
time period, e.g. non-serious events, unlabeled, by quarter.
 Be
aware that the regulatory clock starts when an adverse
event is confirmed. The generic ‘adverse event’ or ‘SAE’ does
not meet the basic element of an AE.
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Summary
To accomplish the objectives of meeting the FDA’s Reporting
Requirements is a collaborative effort for the entire company,
involving not only all of the Drug Safety units, but also
Regulatory Affairs, Clinical, Sales, and Marketing Departments.
[email protected]
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