CLINICAL TRIAL

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Learn different phases of clinical trials, clinical research coordinator, worldwide clinical trials, clinical research associate, clinical data management, clinical trial regulation, clinical trial protocol, clinical research associate training, clinical trial research, clinical trial application and clinical trials training.

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Clinical Trials "Enhancing quality in clinical trials afer implementation of new ICH E6 R2 addendum." 17 th to 19 th SEPTEMBER 2019 | Amsterdam the Netherlands www.aurelius.in Masterclass www.aureliusglobalmasterclass.com masterclass.registrationsaurelius.in +44 203 239 8083

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Key Takeaways Key Topics www.aureliusglobalmasterclass.com masterclass.registrationsaurelius.in +44 203 239 8083 REGISTER ONLINE Course Objectives Tis interactive advanced GCP course is recommended for those who have experience in the clinical trial process and wish to develop their skills. Te course involves active interaction between the trainers and the participants during the presentation. Tere is a lot of group work facilitated by the trainers. Anonymized case studies from real lifewill be used for discussion and problemsolving. Afer the course you will have a good understanding of: Interpretation of the updated GCP requirements and how to implement them in practice with regards of risk-based approach and risk assessment Corrective Action and Preventive Action Risk-based audit and quality plan Sponsor and investigator oversight Handling of protocol deviation Handling of source data Essential requirements of EMA Trial Master File Guidance from Dec. 2018 Safety reporting and Reference Safety Information Requirements to computerised systems and electronic data Handling of investigational medicinal products IMPs Risk assessment Risk management Risk-based monitoring Central monitoring Safety reporting Computerised systems Validation of computerised systems IMP handling according to GCP EU Annex 13 Sponsor investigator oversight QA and audit plan Protocol deviation and CAPA Handling of data eTMF Discover important developments such 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 diferent processes in a clinical trial Explore the most important rules. related to handling of clinical trial data. Gain understanding of trial master fle requirements.

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Y our Prominent Trainer: Jo Burmester Clinical Research Training Consultant Jo is a pharmacology graduate and began her career in clinical research in 1987. She worked as a CRA and senior CRA for 5 years before moving into a full time clinical research training role in 1992. She has designed and delivered clinical research and sof skills training for a wide variety of audiences and has managed training departments in two global organizations. Her career has included experience in the pharmaceutical industry Glaxo Lederle and Wellcome and the CRO world ClinTrials Research and Quintiles and she has worked internationally covering both ICH and FDA requirements. She was a founding Director of Pharma School for 14 years and is now the CEO of JoBurmester.com. She holds a Certifcate in Training and Development from the Chartered Institute of Personnel and Development was a Module Leader on the MSc Program run at Liverpool John Moore’s University. She regularly chairs and speaks at international clinical research conferences and is the author of a book on Continuing Professional Development. Special features Training audience Bring your own case studies that needs to be clarifed All delegates will receive comprehensive course documentation Certifcate of Attendance issued by the trainers 3 Days of Intensive Learning 5H+ Practical Workshops Discussions 6H+ Networking Hands-on examples Clinical Quality Assurance Clinical Auditing Clinical Quality Pharmacovigilance Medical Quality Development Quality Medical Compliance RD QA Clinical CAPA Clinical quality oversight Clinical Data Quality GCP Compliance Clinical Quality Project Management Clinical process management Trial Master Files www.aureliusglobalmasterclass.com masterclass.registrationsaurelius.in +44 203 239 8083 REGISTER ONLINE

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DAY 1 8:30 Registration Welcome Cofee 14:00 Workshop Discussion 10:00 Morning Cofee Networking 15:00 Afernoon Refreshments Networking 15:30 Safety reporting 17:15 Networking 12:30 Luncheon 10:30 Quality Risk Management Risk Assessment and Risk Management 8:25 Welcoming Note and Opening Remarks 9:10 Introduction speed Networking 9:20 Quality Risk Management Risk Assessment and Risk Management 11:30 Risk-based monitoring and Central monitoring 13:30 Risk-based monitoring and Central monitoring • Purpose of quality risk management • How to identify and assess risks • How to mitigate risks • How to review risks • How to communicate and document risks • Risk-based monitoring - since when • Legal changes • Expectations of competent authorities • Who is responsible for monitoring • Central monitoring - since when • Expectations of competent authorities • Program continued • Case studies from delegates • Cases and Discussion: Risk Assessment and Risk Management • Cases and Discussion: Risk-based monitoring and Central monitoring • Review of a small biotech company‘s quality management system • How to create a risk management plan for a GCP-2019 clinical trial • How to do risk-based monitoring for a GCP- 2019 clinical trial • GCP requirements and EU CT-3 guidance for safety reporting • Adverse Events assessment and reporting timelines • Investigator and Sponsor responsibilities in handling of adverse events • SUSAR reporting • Reference Safety Information challenges Case studies will be provided for discussion. • Case studies from delegates www.aureliusglobalmasterclass.com masterclass.registrationsaurelius.in +44 203 239 8083 17:00 Review of Day 1 REGISTER ONLINE

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DAY 2 9:00 Opening remarks from the training leaders 14:00 Sponsor investigator oversight 10:30 Morning Cofee Networking 15:00 Afernoon Refreshments Networking 15:30 Sponsor investigator oversight 16:00 QA and audit plan 17:15 Networking 12:30 Luncheon 11:00 Computerised systems and validation - continued 9:10 Computerised systems and validation 11:30 IMP handling according to GCP and Annex 13 13:30 IMP handling according to GCP and Annex 13 – continued • Know the guidelines and requirements • Understand the legal framework • Understand the expectations of competent authorities • Understand the validation requirements • GCP requirements for the sponsor related to IMP • EU Annex 13 • Handling of IMP at sites • Distribution to sites • Transfer of IMP between sites • Handling of IMP temperature deviations and complaints Case studies will be provided for discussion. • Workshop • Inspection – what is it about • Sponsor investigator obligations • Sponsor investigator tools • Workshop • Organisation • Obligations • Tools • Workshop www.aureliusglobalmasterclass.com masterclass.registrationsaurelius.in +44 203 239 8083 17:00 Review of Day 2 REGISTER ONLINE

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DAY 3 8:30 Protocol deviations and CAP A 15:50 Panel Discussion Session with our esteemed trainers 16:30 Closing remarks from the training leaders 10:30 Morning Cofee Networking 14:40 Afernoon tea networking 12:30 Luncheon 11:00 Handling of Data 11:00 Handling of Data 13:30 eTMF 15:00 eTMF • How to categorise protocol deviations • Protocol deviations as serious breaches • How to handle protocol deviation by the investigator • How to handle protocol deviation by the sponsor • How to prevent protocol deviations Case studies will be provided for discussion. • Storage • Formats • Pitfalls • Workshop and case studies • Guideline and regulation •Transformation – paper and electronics • Storage • Workshop case studies • Case Studies brought up by participants • Panel Discussion • Q A Session • Design your strategy www.aureliusglobalmasterclass.com masterclass.registrationsaurelius.in +44 203 239 8083 REGISTER ONLINE

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Registration Form Clinical Trials | 17 th to 19 th September 2019 | Amsterdam Te Netherlands SALES CONTRACT CONFEREANCE CODE: ACS32_CT PLEASE COMPLETE THIS FORM AND SEND IT BACK TO : Client Identifcation Deatils Please Complete From IN CAPITAL LETTERS for each client EMAIL TO : masterclass.registrationaurelius.in TEL NO : +44 2032 398083 Ms Ms Ms Mrs Mrs Mrs Mr Surname Card Billing Adress : Card Holder’s Name : NAME : Street: Card Holder’s Signature: DATE: City: Card Number: Signature: Visa Eurocard/Mastercard AmEx Diners Club BANK/TELEGRAPHIC TRANSFER Overseas delegates may pay by Telegraphic Transfer CREDIT CARD P AYMENT 3 Transactional Fee Mr Surname Mr Surname Name: Name: Name: Name: V AT Number: Contact Person: Email: Address: City: Country: Phone: Job Title: Job Title: Job Title: Email: Email: Mobile No: Mobile No: Mobile No: Email: Company/Organisation Details V AT No. for EU members / Tax Number for non-EU members Payment Method Post/Zip Code Visa CVC Number or Eurocard/Mastercard CVV last 3 digits on the back of the card Vaild form Expiry Date All Payment must be made within 5 working days from the invoice date Authorization and Acceptance of Sales contract Terms Conditions I hereby declare I am authorised to sign this contract and terms conditions in the name of the company/organisation: Booking is invalid without a signature Agreed Price of the service Delegate Fee Per Participants Normal Registration Sumit Peer Founder / CEO Event Production 2496 Per Delegate 18 € administration charge If you wish to pay in USD or GBP £ please contact us for more details. Aurelius Corporate Solution Pvt Ltd A-125 sector 63 Noida 201 307 Uttar Pradesh India Venue: Y ou can be assured of a comfortable convenient learning environment throughout the duration of the course. We will send out the venue confrmation 2 weeks before the course commences. Accommodation: Accommodation is not included in the registration fee. To reserve hotel accommodation kindly contact : masterclass.registrationsaurelius.in Confrmation Details Afer receiving payment a receipt will be issued. If you do not received a confrmation letter two week before the event kindly contact : masterclass.registrationsaurelius.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 afer 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 the invoice. 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 indemnifes and holds Aurelius CS harmless from and against any and all cost damages and expenses including attorney fees which are incurred by the client. Te construction validity and performance of this contract shall be governed in all respects by the laws of India to the exclusive jurisdiction of whose courts the Parties hereby submit 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 for attendance. In the event that AURELIUS CS permanently cancels the event for any reason whatsoever including but not limited to any force majeure occurrence and provided that the event is not postponed to a later date 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 ofers shall be made. 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. Tis event will not be refunded but can be credited to a future event DATA PROTECTION: Client confrms 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 signed registration form the client hereby consent to AURELIUS CS to keep your details for the use of future marketing activities carried out by AURELIUS CS and third party organization partners. CL IENT hereby agrees that this contract is valid binding enforceable and client has no basis to claim any payment under this contract at anytime is improper disputed or unauthorized in anyway

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In-House TraInIngs Specifc industries face specifc problems. Tey require niche informa- tion and solutions. In-House Training is precisely engineered to your needs. Taking place in the privacy of your company including real-life case studies and best practices the course is led by an independent indus- try expert. We have the best subject matter experts empanelled with us globally which further help us to draf agenda in line of needs which is delivered at the convenient time venue to you. Provide your employees a unique learning experience without having to leave the ofce interruption of work and duties incurring travel costs. Do you need a diferent topic venue or date

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ABOUT AURELIUS Aurelius Corporate Solutions is a frst 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 with almost a decade of experience we facilitate in-sourcing fs- 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 where basis. 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 League University the Management has travelled more than 60 coun- tries for business before starting this Venture. WE ENABLE YOUR PEOPLE TO DELIVER YOUR BUSINESS BETTER So far we have successfully delivered more than 1000 plus unique tech- no-functional in-sourcing projects in and around 30 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 over 30 plus countries. Aurelius has a clan of 100000 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 and contributions done so far. Masterclasses is yet another feather in our hat. Trough 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 provide them to the organizations who need it to reach their true potential. Insourcing Solutions TRAINING Solutions MASTERCLASSES

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