Transcript MONITORING DRUG SAFETY

MONITORING DRUG SAFETY
Sonja Brajovic, M.D., PSI International, Inc., USA
The Path to Drug Safety
Pre Approval Data
• Pre-clinical
• Clinical trials
Known Drug
Class Effects
The Language of Drug Safety
International Conference on Harmonization
(ICH) initiatives are standardizing the global
drug development regulations and maintaining
safeguards on quality, safety and efficacy
Adverse Event
Profile
ICH Guidelines Related to Drug Safety
• E2A – All clinical trials expedited safety reporting
• E2B – Safety reporting data elements
specifications
Post Approval Data
Pharmacovigilance
• E2C – Postmarketing periodic safety reporting PSURs
• M1 – MedDRA as international standard for post
The Safety Signal
marketing reporting
Sources
• New unlabeled adverse events
• M2 – Electronic submission
• Observed increase in labeled event in
• E2D – Post marketing expedited electronic
its severity or specificity
standard
• New interactions
• E2E – Pharmacovigilance planning
• Newly identified at risk population
• Medication error, actual or potential
Process
Generation
Regulatory authorities (EMEA’s EudraVigilance,
Evaluation
Clinical
Significance
FDA-AERS, MHLW) and the regulated
Regulatory
Action
biopharmaceutical industry utilize the Medical
Dictionary for Regulatory Activities (MedDRA)
Safety signals may be identified through clinical trials, known for
the drug class, observed through the adverse event reporting
systems and in medical literature. Clinically significant Safety
signals undergo a continuous Drug Risk Management Process.
through the entire regulatory process, from premarketing to post-marketing, for data entry, retrieval,
evaluation and presentation. MedDRA is a global
terminology with global usage standard and global
Premarketing
Risk Assesment
version synchronization.
Pharmacovigilance
SOC
System Organ Class
MedDRA
Risk Minimization
Program
~330
HLGT
High Level Group Term
HLT
High Level Term
Regular
practices
Periodic
reporting
Withdrawal
from
Market
26
Further
Studies
Label
Modifications
SSC
PT
Preferred Term
~1,700
~16,500
Special Search Category
SMQ
Standard MedDRA Query
PSI INTERNATIONAL, Inc.
10306 Eaton Place, Suite 400 Fairfax, VA 22030 USA Phone +1-703-352-9013 Fax: +1-703-352-8236 Email: [email protected]
WWW.PSIINT.COM
WWW.MEDDRAHELP.COM
LLT
Low Level Term
~c60,000
n9,000