Safety Risk Assessment in Drug Development

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1 Safety Risk Assessment in Drug Development The LA Regional Experience Terezinha C. Teotonio, RN, MSN PPD LA PVG Manager

2 Lessons Learned Globally Need for testing prior to marketing Need for regulations Need for systems to identify AEs Need to correlate drug marketing claims and safety Recognition that some risks can be minimized Drug Information Association 2

3 The LA experience: Pre-approval Expedited Reports SUSAR/Local SAEs Periodic Reports PSUR/Line Listings/DSUR/CIOM S English/Spanish/ Portuguese Hard copy/online submission/ English data/spanish/ Portuguese reports Hard copy-hand delivery/online submission/ Various timelines (72h; 2WD; 7 calendar days, 10 calendar days; 14 calendar days) Various timelines (q 2 months/6 months, yearly and end of study) Drug Information Association 3

4 Expedited Pre-approval Group I ARG / BRA / CHI / COL / MEX / PER Expedited submissions that involve some level of Risk- Benefit assessment since case narratives are required on each SCR Electronic or submission SUSARs/Local SAEs (R and Unrelated) and F-UP mandatory Performed by Local PVG/Reg. Affairs offices directly in the RA Web system Per study or Drug Clock start upon receipt by PVG Drug Information Association 4

5 Expedited Pre-approval Group II ECU / GUA / HAI / DOMR / PAN / PAR / URU / VEN Local SAEs submitted by PIs or Rep Legislation is not clear Follow-up required SCR submission inclusive of case narrative Hard copy or Clock start upon PI knowledge Drug Information Association 5

6 Periodic Pre-approval - All Countries International SUSARs and Local SAEs Line listings-psurs and DSURs Cross-reporting per Drug for various ongoing studies Submitted by Reg. Affairs/PVG LA/PI Involves some level Risk-Benefit analyses and support from sponsors Complexity and clear definitions same as expedited for each group - I and II Drug Information Association 6

7 The LA experience: Post-approval Expedited Report SUSAR/Local SAEs Periodic Report PSUR/Line Listings/CIOMS Spanish/Portuguese Spanish/Portuguese Online submission/ or Fax Various timelines (SAEs 7Wd; 10Wd and non-serious q 2months) Hard copy-hand delivery/online submission/ Various timelines (q 2 months/6 months, yearly PSUR in Mexico all others specific template and LL) RMPs in MEX ARG, PER and BRA Drug Information Association 7

8 Post-approval Expedited & Periodic Reporting Similar to pre-approval additional demands on risk-benefit Gradual requirements from new MAH to older marketed drugs Same level of complexity on same countries and lack of clear regulations on the group II countries previously presented Drug Information Association 8

9 Pre-Post Reporting Methods No harmonization among LA countries for pre and postmarketing reporting methods SCR (single case reports) and periodic reporting for pre and post-approval in most countries Acceptance of DSURs and PSURs/LL across the board, transcribed into local reports Vaccines require specific reporting methods Ongoing updates from LA RAs on how information is processed once received Drug Information Association 9

10 Challenges PM - Drugs in the Market Reports that lack quality HCP reports are on the rise Web-based programs to stimulate reports and opening avenues for immediate reporting Drug Information Association 10

11 Current Challenges Pre and Post-Marketing LA Pre Lack of Harmonization between LA countries Timelines Communication on Updates and changes Outside SUSAR definition for Local Expedited When SUSAR not all countries accept in the language that the CIOMS/MW are generated Line Listings and PSURs versus own templates Post Only ARG-BRA- MEX have online submissions CIOMS/MW submitted in country s national languages Other LA countries own format for Expedited and Periodic submissions Periodic submissions mostly Line listings Risk-benefit mentioned in ARG and BRA Related cases and not only unexpected (non-susar) Drug Information Association 11

12 Global Standards & Guidance Most guidelines applied in LA are based on the EMA guidelines for pre and post-approval Data collected individually (ICRs) and compiled periodic reports DSURs and PSURs EMA harmonization of collection and analyses Recent release Periodic benefit-risk evaluation report (PBRER) Drug Information Association 12

13 From PSUR to PBRER 1996 PSUR-Periodic Safety Updates Report Marketed Drugs-The ICH E2C- Clinical Safety Data Management. Widely accepted in LA on its original format or adapted through line listings and specific RA reports PBRER- Periodic Benefit-Risk Evaluation Report Further development of submission technology including electronic reporting leading to the immediate capture and further evaluation of the benefit-risk evaluation. Implementation undergoing in Latin America. Drug Information Association 13

14 Global and Latin America current challenges How can we transfer pre-approval standards to post-approval? PBRER releases in 2012/13 by the EMA, under cost analyses by all involved and implementation Social Media and the Internet huge demands on drug complains Can we meet consumer s demands? Can we capture all data available? How can we improve PM reporting and awareness in LA? Drug Information Association 14

15 Safety Risk Assessment in Drug development in LA The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. Drug Information Association 15

16 Safety Risk Assessment in Drug development in LA THANK YOU! Drug Information Association 16

17 Safety Risk Assessment in Drug Development The LA Regional Experience Terezinha C. Teotonio, RN, MSN PPD LA PVG Manager

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