advanced cmc
TRANSCRIPT
• Take a closer look on the new Biological entities and Biosimilars
• Experience the development of biotherapeutics from Discovery to
Market approval
• Understand the Strains and Cell line development
• Have a chance to meet the Requirements and technical approach for
Phase I, Phase II, Phase III clinical trials
• Learn about the Control strategy life cycle
• Understand the ICH guidelines and Regulatory pathways for New
Biological entities and Biosimilars in EU and USA
HOW YOU WILL BENEFIT:
www.glceurope.com
Online MasterClass 20-21 October, 2021
Sophie Nageotte
Time Zone:Eastern Standard
Time (EST) - UTC−05:00
Advanced CMC MasterClass
Key points for successful development and registration of products in US
KEy TAKEAwAyS:
• Understandthedifferentlevelsofrequirementsin
CMCduringdevelopmentandpost-approvalphase
• Understandwhataretheessentialrequirements
foradrugsubstance
• LearnhowtojustifythechoiceofRegisteredStarting
Materials(RSM)
• Learnhowtosetappropriatespecificationsfor
bothdrugsubstancesanddrugproducts.
• Understandthepharmaceuticaldevelopmentsection
oftheCTDdossier
• Learnhowtojustifythechoiceoftheexcipients
• Understandtherequirementsforpackagingmaterials
• Overviewofstabilityrequirements
Advanced CMC MasterClass
[email protected] +36 1 848 0515www.glceurope.com
20-21 October, 2021Online MasterClass
INTRoDUCTIoN
METHoDoLoGy
wHo SHoULD ATTEND?
Technical and regulatory requirements for developing a medicinal product are becoming
strictereveryday,theproductsthemselvesbecomemoreandmorecomplex.Thiscoursewill
gothroughthekeyscientificpointsforthedevelopmentandregistrationofyourmedicine,and
provideafocusonUSFDAandEuropeexpectationsforCMC.
Thecoursecoversgeneralrequirementsforsmallmoleculesandbiologics.
The participantswill gain knowledge via lecture-type sessions, letting substantial
time forQ&Aanddiscussions. Furthermore the trainingplacesgreatemphasison
practicalexamplesthroughcasestudies.
• Qualityassurancespecialists
• RegulatoryAffairsCMCauthorsorreviewers
• Analyticalandstabilitylaboratory
• ProjectmanagerswithCMC
• Chemistry,Manufacturing&Controls(CMC)regulatory
• Productscientistsandtestmethodtechnicalexperts(R&DandQC)
• Processanalyticalchemistsandprocessdevelopmentscientists
Advanced CMC MasterClass
[email protected] +36 1 848 0515www.glceurope.com
20-21 October, 2021Online MasterClass
Trainer:
Sophie NageotteRegulatory CMC ExpertIndependant consultant
with over 22 years of experience in the pharmaceutical industry, Sophie has a strong experience in
theCMCRegulatoryfield.ShegainedherMaster’sdegreeinanalyticalchemistryfromManchester
UniversityandherChemicalEngineerdegreefromMontpellierSchoolofChemistry.Shewentonto
work in pharmaceutical development and post-marketing CMC regulatory compliance in companies
suchasBayer,PregLemandLaboratoiresGalderma.Shegainedastrongexperienceintheworldwide
regulatoryenvironmentforthedevelopment,manufactureandcontrolofthemedicines.
Since 2015, she runs her own consultancy, delivering advice in pharmaceutical development
strategies and providing support in writing INDs and IMPDs, CTD Module 3 and QoS, preparing
variationsandansweringquestionsfromhealthauthorities.Herexperiencecoversawiderange
ofproducts(smallmoleculesandbiologics)andpharmaceuticalforms.
Sophie also delivers training courses on European regulations for pharmaceuticals, writing of the
Module 3, how to achieve global regulatory compliance, managing transfers of manufacturing
sitesandpreparingvariationsfortheASEANregion.
Advanced CMC MasterClass
[email protected] +36 1 848 0515www.glceurope.com
20-21 October, 2021Online MasterClass
daY1 daY2
Break10:15
Break10:00
END Endofday112:00
END Endofday212:00
08:00
09:00
10:30
11:00
11:00
11:50
08:00
10:15
Welcome - Introduction to the course
The place of CMC in drug development and lifecycle
• WhatisCMC?• Differentrequirementsatdifferentstages• Thenewparadigm:introductiontoQualitybyDesign• WhatisaQTPP?
Essential data requirements on the drug substance
• GMPforactivesubstances• CriticalQualityAttributes(CQA)• RegisteredStartingMaterials(RSM)• Controlstrategy• EssentialrequirementsandCTDsection3.2.S• Impactofessentialrequirementsonfinishedproduct
Other key topics for the drug substance
• Stability• Additionalconsiderationsforbiologics
Case study and Q&A
• Workonacasestudyinsmallgroups(onlinebreakoutsession)
Case study and Q&A
• Workonacasestudyinsmallgroups(onlinebreakoutsession)
Feedback/Evaluation Session
Key points for the drug product
• Understandingthesection3.2.P.2oftheCTDdossier(pharmaceuticaldevelopment)• Excipients:justifyingtheirchoice• Settingappropriatespecificationsforthefinishedproduct• Packaging
Key points for the drug product (continued)
• Stability
All dates and times are expressed in Eastern Standard Time (EST) on the Agenda - UTC−05:00
07:45 07:45 ConnectingtotheonlineMasterClass ConnectingtotheonlineMasterClass
Advanced CMC MasterClass
[email protected] +36 1 848 0515www.glceurope.com
20-21 October, 2021Online MasterClass
about GLC
Global Leading Conferences (GLC) is an industry leader in the field of business intelligence. We provide interactive & impactful business platforms and networking opportunities for senior level executives by bringing them together for B2B Conferences, Global Summits, Training & Workshops. Being customer focused and having our client’s priorities at the forefront, are amongst our core values and is of high importance to the way we operate our business.Our passion for customer satisfaction and results, drive us to work with industry experts closely - who fully understand their peers interests and day-to-day challenges - in order to deliver the most impactful events. We are specialized in industries such as; Pharmaceutical, Banking & Finance, Energy, Oil & Gas, IT & Communication, Sales & Marketing, Law and Human Resources.Our commitment is to deliver the latest information to our clients, while maintaining highest quality and standards. By attending GLC events your company will be able to apply advanced strategies to your operations, gain the latest know-how’s and benchmark yourself higher against the competition while enjoying a 5 star environment.
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