Different Phases of Worldwide Clinical Trials, Clinical Research Coordinator

1. Masterclass www.aurelius.in ClinicalTrials "Enhancing quality in clinical trialsafter implementation of new ICH E6 R2 addendum." 17th to 19th SEPTEMBER 2019 | Amsterdam, theNetherlands www.aureliusglobalmasterclass.com masterclass.registrations@aurelius.in +44 203 2398083

2. KeyTopics CourseObjectives This interactive advanced GCP course is recommended for those who haveexperience in the clinical trial process and wish to develop theirskills. The course involves active interactionbetween the trainers and theparticipants during the presentation. There is a lot of group work facilitated by the trainers. Anonymizedcase studies from real lifewill be used for discussion andproblemsolving. After the course, you will have agood understandingof: Risk assessment Riskmanagement Risk-basedmonitoring Central monitoring Safety reporting Computerisedsystems Validation of computerisedsystems IMP handling according to GCP EU Annex13 Sponsor & investigator oversight QA and auditplan Protocol deviation andCAPA Handling ofdata (e)TMF KeyTakeaways Discover important developmentssuch as riskbased approaches to trial management &oversight. Develop GCP problem solving skills by considering the most common problems encountered in clinical trials. Have a complete understanding of different processes in a clinical trial Explore the most important rules. related to handling of clinical trialdata. Gain understanding of trial master file requirements. Interpretation of the updated GCP requirements and how to implement themin practice with regards of risk-based approach and riskassessment Corrective Action and PreventiveAction Risk-based audit and quality plan Sponsor and investigator oversight Handling of protocol deviation Handling of sourcedata Essential requirements of EMA Trial Master File Guidance from Dec.2018 Safety reporting and Reference Safety Information Requirements to computerised systemsand electronicdata Handling of investigationalmedicinal products(IMPs) REGISTER ONLINE www.aureliusglobalmasterclass.com masterclass.registrations@aurelius.in +44 203 2398083

3. Your ProminentTrainer: JoBurmester Clinical Research TrainingConsultant Joisapharmacologygraduateandbeganhercareerinclinicalresearchin1987. She worked as a CRA and senior CRA for 5 years before moving into a full time clinical research training role in 1992. Shehasdesignedanddeliveredclinicalresearchandsoft skillstrainingforawidevariety ofaudiencesandhasmanaged training departments in two globalorganizations. Hercareerhasincludedexperienceinthepharmaceuticalindustry (Glaxo, Lederleand Wellcome) andtheCROworld (ClinTrialsResearchandQuintiles)andshehasworkedinternationally,coveringbothICHandFDArequirements. She was a founding Director of Pharma School for 14 years, and is now the CEO of JoBurmester.com. She holds a CertificateinTrainingandDevelopmentfromtheCharteredInstituteofPersonnelandDevelopment,wasaModule Leader on the MSc Program runat Liverpool John Moore’s University. Sheregularlychairsandspeaksatinternationalclinicalresearchconferencesand istheauthor ofabookonContinuing ProfessionalDevelopment. Training audience Clinical QualityAssurance ClinicalAuditing Clinical Quality & Pharmacovigilance MedicalQuality DevelopmentQuality Medical Compliance R&DQA ClinicalCAPA Clinical qualityoversight Clinical Data Quality GCPCompliance Clinical Quality ProjectManagement Clinical processmanagement Trial MasterFiles Specialfeatures Bring your own casestudies that needs to be clarified All delegates will receive comprehensive course documentation Certificate ofAttendance issued by thetrainers 3 Days of IntensiveLearning 5H+ Practical Workshops & Discussions 6H+ Networking Hands-onexamples REGISTER ONLINE www.aureliusglobalmasterclass.com masterclass.registrations@aurelius.in +44 203 2398083

4. DAY1 8:30 Registration &Welcome Coffee 8:25 Welcoming Note andOpening Remarks 9:10 Introduction & speedNetworking • 14:00 Workshop &Discussion • Cases and Discussion: Risk Assessmentand RiskManagement • Cases and Discussion: Risk-based monitoring and Centralmonitoring • Review of a small biotech company‘squality managementsystem • How to create a risk management plan fora GCP-2019 clinicaltrial • How to do risk-based monitoringfor a GCP- 2019 clinicaltrial • 9:20 Quality RiskManagement • Risk Assessment and RiskManagement • Purpose of quality riskmanagement • How to identify and assessrisks • How to mitigaterisks • How to reviewrisks • How to communicate anddocument risks 15:00 Afternoon Refreshments& 10:00 MorningCoffee& Networking Networking 15:30 Safetyreporting • 10:30 Quality RiskManagement • Risk Assessment and RiskManagement • Case studies fromdelegates • GCP requirements and EU CT-3 guidancefor safetyreporting • Adverse Events assessment andreporting timelines • Investigator and Sponsor responsibilitiesin handling of adverseevents • SUSARreporting • Reference Safety Information challenges Case studies will be provided fordiscussion. • 11:30 Risk-based monitoring andCentral monitoring • Risk-based monitoring - sincewhen • Legal changes • Expectations of competentauthorities • Who is responsible formonitoring? • Central monitoring - sincewhen • Expectations of competentauthorities 17:00 Review of Day1 17:15Networking 12:30Luncheon • 13:30 Risk-based monitoring andCentral monitoring • Programcontinued • Case studies fromdelegates REGISTER ONLINE www.aureliusglobalmasterclass.com masterclass.registrations@aurelius.in +44 203 2398083

5. DAY2 9:00 Opening remarks from thetraining leaders 14:00 Sponsor & investigatoroversight • Inspection – what is itabout? • Sponsor & investigatorobligations • Sponsor & investigator tools • 15:00 Afternoon Refreshments& • 9:10 Computerised systems andvalidation • Know the guidelines andrequirements • Understand the legalframework • Understand the expectations ofcompetent authorities • Understand the validationrequirements Networking • 15:30 Sponsor & investigatoroversight • Workshop 10:30 Morning Coffee& Networking 16:00 QA and auditplan • Organisation • Obligations • Tools • 11:00 Computerised systems and validation- continued • Workshop • 11:30 IMP handling according to GCPand Annex13 • GCP requirements for the sponsorrelated toIMP • EU Annex13 • Handling of IMP atsites • Distribution tosites • Transfer of IMP betweensites • Handling of IMP temperaturedeviations andcomplaints • Case studies will be provided fordiscussion. 17:00 Review of Day2 17:15Networking • 12:30Luncheon • 13:30 IMP handling according to GCPand Annex 13 –continued • Workshop REGISTER ONLINE www.aureliusglobalmasterclass.com masterclass.registrations@aurelius.in +44 203 2398083

6. DAY3 • 8:30 Protocol deviations andCAPA • How to categorise protocoldeviations • Protocol deviations as seriousbreaches • How to handle protocol deviation bythe investigator • How to handle protocol deviation bythe sponsor • How to prevent protocoldeviations • Case studies will be provided fordiscussion. • 10:30 Morning Coffee& Networking • 11:00 Handling ofData • Storage • Formats • Pitfalls • 11:00 Handling ofData • Workshop and casestudies • 12:30Luncheon • 13:30eTMF • Guideline andregulation • Transformation – paper andelectronics • Storage • 14:40 Afternoon tea& networking • 15:00eTMF • Workshop & casestudies • 15:50 Panel Discussion Session withour esteemedtrainers • Case Studies brought up byparticipants • PanelDiscussion • Q & ASession • Design yourstrategy • 16:30 Closing remarks from thetraining • leaders REGISTER ONLINE www.aureliusglobalmasterclass.com masterclass.registrations@aurelius.in +44 203 2398083

7. RegistrationForm Clinical Trials | 17th to 19th September 2019 | Amsterdam, TheNetherlands PaymentMethod BANK/TELEGRAPHIC TRANSFER (Overseas delegates may payby TelegraphicTransfer) CREDIT CARD PAYMENT (3% TransactionalFee) SALESCONTRACT CONFEREANCE CODE:ACS32_CT PLEASE COMPLETE THIS FORM AND SEND IT BACK TO: EMAILTO: masterclass.registration@aurelius.in TELNO: +44 2032398083 Visa Eurocard/Mastercard AmEx Card BillingAdress : Street: City: Post/ZipCode Card Holder’sName: CardHolder’sSignature: CardNumber: DinersClub Client IdentificationDeatils (Please Complete From IN CAPITAL LETTERS for eachclient) Ms Mrs MrSurname Name: JobTitle: Email: MobileNo: Visa CVC Number or Eurocard/MastercardCVV (last 3 digits on the back of thecard) Vaildform ExpiryDate Ms Mrs Name: MrSurname (All Payment must be made within 5 working days from the invoicedate) Authorization and Acceptanceof Sales contract & Terms & Conditions IherebydeclareIamauthorisedtosignthiscontractandterms & conditions in the name of thecompany/organisation: NAME: DATE: Signature: Booking is invalid without asignature JobTitle: Email: MobileNo: Ms Mrs MrSurname Name: JobTitle: Email: MobileNo: Company/OrganisationDetails Name: VATNumber: (VAT No. for EU members / Tax Number for non-EUmembers) Agreed Price of theservice Delegate Fee PerParticipants 2496 NormalRegistration PerDelegate ContactPerson: Email: Address: City: Country: Phone: 18 € administrationcharge Ifyouwishtopay inUSD($)orGBP (£)pleasecontactusformoredetails. EventProduction Aurelius Corporate Solution PvtLtd A-125, sector 63, Noida 201 307 Uttar Pradesh,India Sumit Peer, Founder /CEO Venue:Youcanbeassuredofacomfortable,convenientlearningenvironmentthroughoutthedurationof thecourse.We willsendoutthevenueconfirmation2 weeks before thecoursecommences. Accommodation: Accommodation is not included in the registration fee. To reserve hotel accommodation kindly contact : masterclass.registrations@aurelius.in Confirmation Details After receiving payment a receipt will be issued. If you do not received a confirmation letter two week before the event kindly contact :masterclass.registrations@aurelius.in Cancellation Terms & Conditions: CANCELLATION must be received in writing at least 30 days before the event. All bookings carry a 50% cancellation fee immediately after a signed contract has been received by Aurelius CS. Cancellation within 7 days notice from the event date will not be able to obtain a full credit for any future events. NO Refund will be made available. Upon the completion and receipt of the registration form, payment is required within 5 working days of the issuance of theinvoice. Indemnity Should for an reason outside the control of Aurelius CS training & Consultancy, the venue or trainer ‘s change, or the event being cancelled due to an act of terrorism, extreme weather conditions or industrial actions, Aure- lius CS shall Endeavour to reschedule but client hereby indemnifies and holds Aurelius CS harmless from and against any and all cost, damages and expenses, including attorney fees which are incurred by the client. The construction, validityandperformance ofthiscontractshall begovernedinall respects bythelaws ofIndiatotheexclusive jurisdiction of whosecourtsthePartiesherebysubmit FEES are inclusive of refreshments & course materials. Walk-in delegates with payment will only be admitted on the basis of space availability at the event and with immediate full payment. Full payment prior to the event is mandatory forattendance.Inthe eventthatAURELIUSCSpermanently cancelstheeventfor any reason whatsoever,(including,butnotlimitedto anyforce majeureoccurrence)andprovidedthattheeventisnotpostponedto alaterdate nor is merged with another event, the Client shall receive a credit voucher for the amount that the Client has paid to such permanently cancelled event, valid for up to one year to be used at another AURELIUS CS event. No refunds, part refunds or alternative offers shall bemade. AURELIUS CS reserves the rights to make any amendments and/or changes to the courses, venue, trainer and/or topics if warranted by circumstances beyond its control. AURELIUS CS reserves the rights to postpone or reschedule any events prior a week before the date of the event. By signing this contract, client agrees that in case of dispute or cancellation of this contract AURELIUS CS will not be able to mitigate losses for any less than 50% of the total contract value. If, for any reason, AURELIUS CS decides to cancel or postpone this event, AURELIUS CS is not responsible for covering airfare, hotel, or other travel cost incurred by clients. This event will not be refunded, but can be credited to a futureevent DATA PROTECTION: Client confirms that it has requested and consented to AURELIUS CS database to use by AURELIUS CS and passed to selected third parties, to assist in communicating which may be of interest to the client. COPYRIGHTS etc: All intellectual property rights in all materials produce or distributed by AURELIUS CS is expressively reserved and any unauthorized duplications, publications or distributions is prohibited Upon receiving the signedregistrationform,theclientherebyconsenttoAURELIUSCSto keepyourdetailsfortheuse offuturemarketing activities carriedoutby AURELIUSCSandthirdparty&organizationpartners. CL IENThereby agreesthatthiscontract is valid, binding&enforceable; andclienthasno basisto claim any paymentunderthiscontractatanytimeisimproper,disputedorunauthorizedinanyway

8. In-HouseTraInIngs Specific industries face specific problems. They require nicheinforma- tion and solutions. In-House Training is precisely engineered to your needs. Taking place in the privacy of your company, including real-life case studiesandbestpractices,thecourseisled byanindependentindus- tryexpert. We have the best subject matter experts (empanelled with us) globallywhichfurtherhelpustodraftagendainlineofneeds& which is delivered at the convenient time & venue toyou. Provide your employees a unique learning experience withouthaving to leave the office, interruption of work and duties & incurring travel costs. Do you need a differenttopic, venue ordate?

9. InsourcingSolutions TRAININGSolutions ABOUT AURELIUS MASTERCLASSES WE ENABLE YOUR PEOPLE TODELIVER YOUR BUSINESSBETTER So far we have successfully delivered more than 1000 plus unique tech- no-functional in-sourcing projects, in and around30 countries. We today boost of 700 plus corporate customers most of which are Fortune 500 compa- nies. We have enabled more than 70 K plus professionals worldwide in over30 plus countries. Aurelius has a clan of 100,000 plus clan of global SME empan- neled worldwide and there are about 100 plus media houses and publications nationally and internationally which have written about Aurelius and spoken for the work andcontributions done so far. Aurelius Corporate Solutions is a first of its kind on demand Insourcing Multiplier. We are a one stop shop for all technical and functional Insourcing Needs. Being an In-sourcing Multiplier, withalmost a decade of experience we facilitate in-sourcing fis- sion across organization (technical and functional), by enabling your people to do your business better. We are a one of its kind Insourcing Multiplier – we help solve business problems, this is done through our clan of empanelled SMEs real time on anytime any wherebasis. Aurelius gets its farsighted and guiding path light from its Founding Leaders, who bring with them several decades of technology sales and marketing experience, coming from an IVY LeagueUniversity, the Management has travelled more than 60 coun- tries for business before starting thisVenture. Masterclasses is yet another feather in ourhat. Through these advanced Mas- terclasses we are able to provide solutions to some of the most complex and advanced subjects within the industry. We believe we can source and channel the most complex and updated knowledge in various industrial sectors and providethemtotheorganizationswhoneedittoreachtheirtruepotential.