US Prescribing Information & Safety Labeling April 22 April 23, 2013 PERI Training Facility ~ Arlington, Virginia

Transcription

1 Tentative Agenda US Prescribing Infrmatin & Safety Labeling April 22 April 23, 2013 PERI Training Facility ~ Arlingtn, Virginia Mnday, April 22, 2013 Tab N. 7:30 8:00 AM Registratin and Cntinental Breakfast 8:00 8:30 AM PERI Welcme Address Staff Pharmaceutical Educatin and Research Institute, Inc. (PERI) Curse Overview Dr. med. A. Leander Fntaine Curse Directr President, Pharmaceutics LLC Managing Directr, Pharmaceutics Labeling Services LLC Managing Directr, Pharmaceutics Cnsulting and Training LLC 8:30 9:30 AM US Prescribing Infrmatin With and Withut Highlights - Overview Dr. med. A. Leander Fntaine Curse Directr 4 Regulatry histry and reasns fr the change in frmat Overall architecture and cherence f US Prescribing Infrmatin with Highlights Cntrast frmat and cntent between ld and new Hw the new frmat is expected t be used in typical clinical situatins FDA s cmmitment t useful adverse reactin infrmatin 9:30 10:30 AM Cntent and Frmat f the Adverse Reactins Sectin f PI With Highlights Dr. med. A. Leander Fntaine 5 FDA s definitin and illustratin f the cncept adverse reactin fr the purpses f prescribing infrmatin - The meaning f reasnable pssibility and [causal] assciatin The difference between suspected adverse reactins fr the purpses f IND safety reprting and adverse reactins fr the purpses f labeling The meaning f reasnable pssibility (a criterin used in the cntext f IND safety reprting) FDA s use f the term adverse event Scpe f the sectin: Observed and class reactins Which data and infrmatin t lk at when trying t identify adverse reactins Other factrs t cnsider when deciding if an events deserves inclusin Default sectin substructure and standard cntent

2 Tw distinct steps fr generating infrmatin abut clinical trials experience: Identificatin f adverse reactins, fllwed by the selectin f the data set fr illustrating the frequency f selected reactins The cnsequences f disregarding this cnceptual 2-step separatin Special cnsideratins fr serius and nn-serius, cmmn and infrequent reactins What t d if rate cmparisns are nt helpful in identifying a ptential causal assciatin FDA s cascade fr selecting the dataset t illustrate the prbability f reactins that are included in the table f cmmn reactins Brief cmparisn with ther agencies rules fr prviding frequency infrmatin Hw t decide where t cut ff the table f cmmn reactins Hw t describe the selectin f data presented in the table f cmmn reactins What t d with nn-cmmn reactins Is there a frequency cut-ff fr the Adverse Reactins sectin as such? 10:30 AM 10:45 AM Refreshment Break 10:45 PM 12:45 PM Cntent and Frmat f the Adverse Reactins Sectin f PI With Highlights (cnt.) Dr. med. A. Leander Fntaine 6 Hw t decide where t cut ff the table f cmmn reactins Hw t describe the selectin f data presented in the table f cmmn reactins What t d with nn-cmmn reactins? Is there a frequency cut-ff fr the Adverse Reactins sectin as such? Hw t decide which class reactins t include? Dealing with the presence r absence f differences in the safety prfiles fr different indicatins, ppulatins etc. The requirement t lk behind cded terms, use meaningful terminlgy, and create cntext in adverse reactin tables and lists Transitining frm a list f expected reactins in the Investigatr Brchure t labeling When (nt) t cpy the presentatin f infrmatin in ther labels? Hw t deal with FDA s lack f cmpliance with their wn guidelines? Are there apprved labels with an Adverse Reactins sectin that cmplies with FDA s 2006 guidance Using FDA s way as a template fr cre labeling and labeling in ther markets? A critical review f sme elements in FDA s Safety Reviewer Guidance Frequently bserved tensins between US requirements and EUminded Cmpany Cre Data Sheets The need fr regular review f the cntent f the Adverse Reactins and ther sectins...and mre Discuss and Begin Practice exercise: Cmpsing a cmplete Adverse Reactins sectin in cmpliance 2

3 12:45 1:45 PM Lunch n yur wn with 21 CFR and FDA s 2006 guidance - Part 1 1:45 2:45 PM Practice Exercise (cnt.) Cmpse a cmplete Adverse Reactins sectin in cmpliance with 21 CFR and FDA s 2006 guidance - Part 2 7 2:45 3:00 PM Refreshment Break 3:00 5:00 PM Cntent and frmat f the Warnings and Precautins and Use in Specific Ppulatins sectins 8 5:00 5:15 PM Questins & Wrap up Warnings and Precautin The meaning f reasnable evidence f a causal assciatin, the threshld fr adding risks t Warnings and Precautins as sn as it is reached Cnflicting interpretatins f the threshld by FDA? Is there a difference between reasnable evidence f a causal assciatin and reasnable [causal] assciatin (the threshld fr the Adverse Reactin sectin) Factrs t cnsider when deciding if a risk deserves t be elevated t Warnings and Precautins FDA s interpretatin f clinical significance When t elevate interactins? Sectin substructure and rder f tpics Which infrmatin t prvide in a warning statement Frequently bserved tensins between US requirements and EU-minded Cmpany Cre Data Sheets Use in Specific Ppulatins Hw this sectin relates t Warnings and Precautins, and hw t adjust verlap Examples f nn-standard specific ppulatins Hw t get ready fr FDA s expected final rule n pregnancy and lactatin labeling Understanding FDA s prpsed categrizatin f reprductive txicity Tuesday, April 23, :30 8:00 AM Cntinental Breakfast 8:00 10:00 AM Cntent and frmat f the Indicatins and Usage and Cntraindicatins sectins 9 Describing the target ppulatin fr use in psitive and negative terms Definitins: Indicatin, nn-indicatin, cntraindicatin 3

4 Understanding the cncept benefit/risk balance and the 4 types f factrs t be weighed Indicatins and Usage Indicatins and Usage Typical elements f this sectin Ptential verlap with the Cntraindicatins sectin Cntraindicatins Cntraindicatins When t cntraindicate? 10:00 10:15 AM Refreshment Break When t address an excluded ppulatin subset under cntraindicatins, when under Indicatins and Usage Wrding t express that a cnditin is cntraindicated Disclsing the reasn behind a cntraindicatin What t d with relative cntraindicatins FDA s apprach t hypersensitivity cntraindicatins Hw and where t address discntinuatin and reexpsure after serius adverse reactins? 10:15 12:0 PM The Interactins sectin and interactins-related infrmatin in ther sectins Dr. med. A. Leander Fntaine 10 12:00 1:00 PM Lunch n yur wn What are clinically significant interactins? Hw certain d we have t be abut causality? What are interactins fr the purpse f prescribing infrmatin? What t present under Clinical Pharmaclgy? When t elevate interactins t Warnings and Precautins? When t cntraindicate cncmitant use? 1:00 2:00 PM Essential cnsideratins fr ppulating ther sectins f FPI 11 Dr. med. A. Leander Fntaine Dsage and Administratin: Overlap with Warnings and Precautins Clinical Pharmaclgy: Deciding what t include in Mechanism f Actin versus Pharmacdynamics - Critical review f sme elements f FDA s draft guidance Clinical Studies: The essence f FDA s guidance n frmat and cntent Patient Cunseling Infrmatin: Selecting talking pints fr prescribers - Referencing FDA-apprved patient labeling An apprach t ensuring cmpliance with , and

5 2:00 3:00 PM Creating the Highlights f Prescribing Infrmatin (includes Refreshment break) 12 Dr. med. A. Leander Fntaine 3:00 3:15 PM Refreshment Break Hw t write gd Highlights Hw the drafting f Highlights helps imprve the quality f FPI Rules fr designing the Prduct Title FDA s highlights template What t d if my draft Highlights are t lng? Grup exercise: The cmplete prcess f selecting infrmatin fr, and drafting, Highlights fr a fictitius prduct 3:15 4:00 PM Frmal and frmatting requirements - Aviding cmmn mistakes 13 Dr. med. A. Leander Fntaine Frmatting the MSWrd versin fr submissin Requirements fr printed labeling Hw t append patient labeling Crss-references (frmat and use) Things t avid 4:00 4:30 PM Cnverting ld-frmat PI int PI with Highlights An ecnmical standard prcess Hw t visualize and explain what has been changed Typical changes and additins t cntent 14 4:30 4:45 PM Wrap up & Questins 5

6 CONTINUING EDUCATION CREDIT Pharmaceutical Educatin & Research Institute, Inc. (PERI) is pleased t make cntinuing educatin credit available t yu fr attendance at this prgram. T receive credit, yu must attend the entire prgram and submit bth the Cntinuing Educatin Applicatin frm and the prgram evaluatin directly t a PERI n-site crdinatr. A cntinuing educatin certificate r Statement f Credit will be distributed t yu within three weeks f this prgram. Pharmacy Pharmaceutical Educatin & Research Institute, Inc. (PERI) is accredited by the Accreditatin Cuncil fr Pharmacy Educatin as a prvider f cntinuing pharmacy educatin. ACPE Universal Activity Number is # L03, 1.4 cntinuing educatin units (CEUs) are available fr this prgram. Initial Release Date: 04/22/2013. This is an applicatin based CPE Activity. Medical is accredited by the Accreditatin Cuncil fr Cntinuing Medical Educatin t prvide cntinuing medical educatin fr physicians. designates this live activity fr a maximum f 14 AMA PRA Categry 1 Credit(s) TM. Physicians shuld claim nly the credit cmmensurate with the extent f their participatin in the activity Pharmaceutical Educatin and Research Institute, Inc. (PERI) All Rights Reserved 6

7 7