MONITORING DRUG SAFETY Sonja Brajovic M D PSI

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 International Conference on Harmonization (ICH) initiatives are standardizing the global drug development regulations and maintaining safeguards on quality, safety and efficacy Se ar ch Da ta The Language of Drug Safety in pu t Adverse Event Profile ICH Guidelines Related to Drug Safety • E 2 A – All clinical trials expedited safety reporting • E 2 B – Safety reporting data elements specifications Post Approval Data Pharmacovigilance • E 2 C – Postmarketing periodic safety reporting PSURs • M 1 – Med. DRA as international standard for post The Safety Signal marketing reporting Sources • M 2 – Electronic submission • New unlabeled adverse events • Observed increase in labeled event in • E 2 D – Post marketing expedited electronic its severity or specificity standard • New interactions • Newly identified at risk population • E 2 E – Pharmacovigilance planning • Medication error, actual or potential Process Generation Regulatory authorities (EMEA’s Eudra. Vigilance, FDA Evaluation Clinical Significance -AERS, MHLW) and the regulated biopharmaceutical Regulatory Action industry utilize the Medical Dictionary for Regulatory 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. Activities (Med. DRA) through the entire regulatory process, from pre-marketing to post-marketing, for data entry, retrieval, evaluation and presentation. Med. DRA is a global terminology with global usage standard and global version synchronization. Premarketing Risk Assesment Pharmacovigilance SOC System Organ Class Med. DRA 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 Special Search Category SMQ Standard Med. DRA Query PSI INTERNATIONAL, Inc. 10306 Eaton Place, Suite 400 Fairfax, VA 22030 USA Phone +1 -703 -352 -9013 Fax: +1 -703 -352 -8236 Email: info@psiint. com WWW. PSIINT. COM WWW. MEDDRAHELP. COM ~1, 700 ~16, 500 PT Preferred Term ~c 60, 000 n 9, 000 LLT Low Level Term