Safety Signal Detection 2012 Agenda

Untitled Document

*Denotes Inclusion of Real-Life Scenarios or Case Histories

DAY ONE

8:00 a.m. – 9:00 a.m.

Registration/Continental Breakfast

9:00 a.m. – 10:30 a.m.

FDA Regulatory Requirements for Clinical Safety and Postmarketing Pharmacovigilance

  • Regulatory history and actions*
  • Need for postmarketing pharmacovigilance*
  • Current FDA regulations (drugs, biologicals [including vaccines]) for premarketing: clinical safety and postmarketing pharmacovigilance
  • Center for Drug Evaluation and Research (CDER) safety-related structure
  • Food and Drug Administration Amendments Act of 2007 (FDAAA)

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:00 p.m.

Adverse Event Reports: Multiple Sources, Multiple Issues

  • Clinical pharmacologic basis of adverse drug events (ADEs)*
  • Signal generation and detection
  • Hypothesis generation
  • Factors in evaluating strength of association and causality*
  • Clinical evaluation of individual case reports, including identified risk factors*
  • FDA Guidance: Premarketing Risk Assessment

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 3:00 p.m.

Adverse Event Reports: Multiple Sources, Multiple Issues CONTINUED

  • ICH E2D: Post-approval safety data management: definitions and standards for expedited reporting
  • Strengths and limitations of spontaneous reports data*
  • Fostering quality AE data in clinical trials and postmarketing vigilance via active query and applied clinical expertise*
  • Case definition and clinical evaluation*
  • Case follow-up
  • FDA proposed rule (postmarketing)
  • MedDRA® strengths and limitations

3:00 p.m. – 3:15 p.m.

Break

3:15 p.m. – 4:00 p.m.

EU Regulatory Requirements for Clinical Safety and Postmarketing Pharmacovigilance – An Update

4:00 p.m. – 4:30 p.m.

Hands-On Exercise in Clinical Pharmacology and Case Assessment

4:30 p.m.

Session Wrap-up

DAY TWO

8:00 a.m. – 9:00 a.m.

Registration/Continental Breakfast

9:00 a.m. – 10:30 a.m.

Labeling: Regulatory Requirements and Relation to Signal Detection and Evaluation

  • CFR 201 & FDA final labeling rule
  • Boxed warning & warnings and precautions   
  • Approved labeling changes
  • “Changes Being Effected” supplements 
  • EU Guideline on Summary of Product Characteristics (SmPC) 
  • Safety-related label revisions
  • Label as risk management tool
  • Medication errors

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:00 p.m.

Risk Management, Data Mining and Epidemiology

  • FDA Task Force on Risk Management
  • FDA Guidance: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment
  • Data mining: concepts and applications*
  • Epidemiology in product development and safety surveillance*

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 2:00 p.m.

Inspections for Clinical Safety and Postmarketing Pharmacovigilance

  • FDA and EU inspectional approaches  
  • Ongoing assessment and formal audits of company processes and procedures
  • SOPs/other procedural documents: lessons learned for global compliance and quality

2:00 p.m. – 2:30 p.m.

ICH E2E: Pharmacovigilance Planning

2:30 p.m. – 3:00 p.m.

Hands-On Exercise in Labeling Revision

3:00 p.m. – 3:15 p.m.

Break

3:15 p.m. – 4:15 p.m.

Assessment, Communication and Management of Medical Product Risk: How Effective is Effective Enough?

4:15 p.m.

Adjourn Workshop