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www.aurelius.in Masterclass Clinical Trials "Enhancing quality in clinical trials after implementation of new ICH E6
Masterclass
Masterclass

Clinical Trials

"Enhancing quality in clinical trials after implementation of new ICH E6 R2 addendum."

trials after implementation of new ICH E6 R2 addendum." 17 t h to 19 t h

17 th to 19 th SEPTEMBER 2019 | Amsterdam, the Netherlands

www.aureliusglobalmasterclass.com

Amsterdam, the Netherlands www.aureliusglobalmasterclass.com + 4 4 2 0 3 2 3 9 8 0 8

+44 203 239 8083

masterclass.registrations@aurelius.in

Key Topics

Risk assessmentKey Topics Risk management Risk-based monitoring Central monitoring Safety reporting Computerised systems Validation of

Risk managementKey Topics Risk assessment Risk-based monitoring Central monitoring Safety reporting Computerised systems Validation of

Risk-based monitoringKey Topics Risk assessment Risk management Central monitoring Safety reporting Computerised systems Validation of

Central monitoringTopics Risk assessment Risk management Risk-based monitoring Safety reporting Computerised systems Validation of

Safety reportingRisk management Risk-based monitoring Central monitoring Computerised systems Validation of computerised systems IMP

Computerised systemsRisk-based monitoring Central monitoring Safety reporting Validation of computerised systems IMP handling according to

Validation of computerised systemsCentral monitoring Safety reporting Computerised systems IMP handling according to GCP EU Annex 13 Sponsor &

IMP handling according to GCPComputerised systems Validation of computerised systems EU Annex 13 Sponsor & investigator oversight QA and

EU Annex 13of computerised systems IMP handling according to GCP Sponsor & investigator oversight QA and audit plan

Sponsor & investigator oversightsystems IMP handling according to GCP EU Annex 13 QA and audit plan Protocol deviation and

QA and audit planto GCP EU Annex 13 Sponsor & investigator oversight Protocol deviation and CAPA Handling of data

Protocol deviation and CAPA13 Sponsor & investigator oversight QA and audit plan Handling of data (e)TMF Key Takeaways Discover

Handling of dataoversight QA and audit plan Protocol deviation and CAPA (e)TMF Key Takeaways Discover important developments such

(e)TMFand audit plan Protocol deviation and CAPA Handling of data Key Takeaways Discover important developments such

Key Takeaways

Discover important developments such as riskbased approaches to trial management & oversight.deviation and CAPA Handling of data (e)TMF Key Takeaways Develop GCP problem solving skills by considering

Develop GCP problem solving skills by considering the most common problems encountered in clinical trials.as riskbased approaches to trial management & oversight. Have a complete understanding of different processes in

Have a complete understanding of different processes in a clinical trialthe most common problems encountered in clinical trials. Explore the most important rules. related to handling

Explore the most important rules. related to handling of clinical trial data.understanding of different processes in a clinical trial Gain understanding of trial master file requirements. Course

Gain understanding of trial master file requirements.important rules. related to handling of clinical trial data. Course Objectives This interactive advanced GCP course

Course Objectives

This interactive advanced GCP course is recommended for those who have experience in the clinical trial process and wish to develop their skills. The course involves active interaction between the trainers and the participants during the presentation. There is a lot of group work facilitated by the trainers. Anonymized case studies from real lifewill be used for discussion and problemsolving. After 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 assessmentAfter the course, you will have a good understanding of: Corrective Action and Preventive Action Risk-based

Corrective Action and Preventive Actionwith regards of risk-based approach and risk assessment Risk-based audit and quality plan Sponsor and investigator

Risk-based audit and quality planand risk assessment Corrective Action and Preventive Action Sponsor and investigator oversight Handling of protocol

Sponsor and investigator oversightand Preventive Action Risk-based audit and quality plan Handling of protocol deviation Handling of source data

Handling of protocol deviationaudit and quality plan Sponsor and investigator oversight Handling of source data Essential requirements of EMA

Handling of source dataand investigator oversight Handling of protocol deviation Essential requirements of EMA Trial Master File Guidance

Essential requirements of EMA TrialHandling of protocol deviation Handling of source data Master File Guidance from Dec. 2018 Safety reporting

Master File Guidance from Dec. 2018Handling of source data Essential requirements of EMA Trial Safety reporting and Reference Safety Information

Safety reporting and Reference Safety Informationof EMA Trial Master File Guidance from Dec. 2018 Requirements to computerised systems and electronic data

Requirements to computerised systems and electronic dataDec. 2018 Safety reporting and Reference Safety Information Handling of investigational medicinal products (IMPs)

Handling of investigational medicinal products (IMPs)Requirements to computerised systems and electronic data www.aureliusglobalmasterclass.com + 4 4 2 0 3 2 3

www.aureliusglobalmasterclass.com

medicinal products (IMPs) www.aureliusglobalmasterclass.com + 4 4 2 0 3 2 3 9 8 0 8

+44 203 239 8083

masterclass.registrations@aurelius.inmedicinal products (IMPs) www.aureliusglobalmasterclass.com + 4 4 2 0 3 2 3 9 8 0 8

+ 4 4 2 0 3 2 3 9 8 0 8 3 masterclass.registrations@aurelius.in REGISTER ONLINE

REGISTER

ONLINE

Your Prominent Trainer:

Your Prominent Trainer: Jo Burmester Clinical Research Training Consultant Jo is a pharmacology graduate and began

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 soft 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 Certificate 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.

Training audience

Clinical Quality Assuranceon Continuing Professional Development. Training audience Clinical Auditing Clinical Quality & Pharmacovigilance

Clinical AuditingDevelopment. Training audience Clinical Quality Assurance Clinical Quality & Pharmacovigilance Medical Quality

Clinical Quality & Pharmacovigilanceaudience Clinical Quality Assurance Clinical Auditing Medical Quality Development Quality Medical Compliance

Medical QualityClinical Auditing Clinical Quality & Pharmacovigilance Development Quality Medical Compliance R&D QA Clinical

Development QualityClinical Quality & Pharmacovigilance Medical Quality Medical Compliance R&D QA Clinical CAPA Clinical quality

Medical Compliance& Pharmacovigilance Medical Quality Development Quality R&D QA Clinical CAPA Clinical quality oversight Clinical

R&D QAMedical Quality Development Quality Medical Compliance Clinical CAPA Clinical quality oversight Clinical Data

Clinical CAPAQuality Development Quality Medical Compliance R&D QA Clinical quality oversight Clinical Data Quality GCP

Clinical quality oversightQuality Medical Compliance R&D QA Clinical CAPA Clinical Data Quality GCP Compliance Clinical Quality

Clinical Data QualityR&D QA Clinical CAPA Clinical quality oversight GCP Compliance Clinical Quality Project Management Clinical

GCP ComplianceCAPA Clinical quality oversight Clinical Data Quality Clinical Quality Project Management Clinical process

Clinical Quality Project Managementquality oversight Clinical Data Quality GCP Compliance Clinical process management Trial Master Files

Clinical process managementQuality GCP Compliance Clinical Quality Project Management Trial Master Files www.aureliusglobalmasterclass.com + 4 4

Trial Master FilesQuality Project Management Clinical process management www.aureliusglobalmasterclass.com + 4 4 2 0 3 2 3

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Trial Master Files www.aureliusglobalmasterclass.com + 4 4 2 0 3 2 3 9 8 0 8

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+ 4 4 2 0 3 2 3 9 8 0 8 3 Special features Bring

Special features

Bring your own case studies that needs to be clarified+ 4 4 2 0 3 2 3 9 8 0 8 3 Special features All

All delegates will receive comprehensive course documentationBring your own case studies that needs to be clarified Certificate of Attendance issued by the

Certificate of Attendance issued by the trainersdelegates will receive comprehensive course documentation 3 Days of Intensive Learning 5H+ Practical Workshops &

3 Days of Intensive LearningCertificate of Attendance issued by the trainers 5H+ Practical Workshops & Discussions 6H+ Networking

5H+ Practical Workshops & Discussionsissued by the trainers 3 Days of Intensive Learning 6H+ Networking Hands-on examples

6H+ NetworkingIntensive Learning 5H+ Practical Workshops & Discussions Hands-on examples masterclass.registrations@aurelius.in R E

Hands-on examples5H+ Practical Workshops & Discussions 6H+ Networking masterclass.registrations@aurelius.in R E G I S T E R

masterclass.registrations@aurelius.in

& Discussions 6H+ Networking Hands-on examples masterclass.registrations@aurelius.in R E G I S T E R ONLINE

REGISTER

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DAY 1 8:30 Registration & Welcome Coffee 8:25 Welcoming Note and Opening Remarks 9:10 Introduction

DAY 1

DAY 1 8:30 Registration & Welcome Coffee 8:25 Welcoming Note and Opening Remarks 9:10 Introduction &

8:30 Registration & Welcome Coffee

8:25 Welcoming Note and Opening Remarks

9:10 Introduction & speed Networking

9:20 Quality Risk Management Risk Assessment and Risk Management

• 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

10:00 Morning Coffee & Networking

and document risks 10:00 Morning Coffee & Networking 10:30 Quality Risk Management Risk Assessment and Risk

10:30 Quality Risk Management Risk Assessment and Risk Management

Case studies from delegates

11:30 Risk-based monitoring and Central monitoring

• Risk-based monitoring - since when

• Legal changes

• Expectations of competent authorities

• Who is responsible for monitoring?

• Central monitoring - since when

• Expectations of competent authorities

12:30 Luncheon

• Expectations of competent authorities 12:30 Luncheon 14:00 Workshop & Discussion • Cases and Discussion:
• Expectations of competent authorities 12:30 Luncheon 14:00 Workshop & Discussion • Cases and Discussion:

14:00 Workshop & Discussion

• 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

15:00 Afternoon Refreshments & Networking

clinical trial 15:00 Afternoon Refreshments & Networking 15:30 Safety reporting • GCP requirements and EU CT-3

15:30 Safety reporting

• 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.

17:00 Review of Day 1

17:15 Networking

for discussion. 17:00 Review of Day 1 17:15 Networking 13:30 Risk-based monitoring and Central monitoring •

13:30 Risk-based monitoring and Central monitoring

• Program continued

• Case studies from delegates

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+ 4 4 2 0 3 2 3 9 8 0 8 3 masterclass.registrations@aurelius.in REGISTER ONLINE

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DAY 2

9:00 Opening remarks from the training leaders

9:10 Computerised systems and validation

• Know the guidelines and requirements

• Understand the legal framework

• Understand the expectations of competent

authorities

• Understand the validation requirements

authorities • Understand the validation requirements 10:30 Morning Coffee & Networking 11:00 Computerised

10:30 Morning Coffee & Networking

11:00 Computerised systems and validation - continued • Workshop

11:30 IMP handling according to GCP and Annex 13

• 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.

and complaints Case studies will be provided for discussion. 12:30 Luncheon 13:30 IMP handling according to

12:30 Luncheon

13:30 IMP handling according to GCP and Annex 13 – continued • Workshop

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+ 4 4 2 0 3 2 3 9 8 0 8 3 14:00 Sponsor &
+ 4 4 2 0 3 2 3 9 8 0 8 3 14:00 Sponsor &

14:00 Sponsor & investigator oversight

• Inspection – what is it about?

• Sponsor & investigator obligations

• Sponsor & investigator tools

obligations • Sponsor & investigator tools 15:00 Afternoon Refreshments & Networking 15:30 Sponsor

15:00 Afternoon Refreshments & Networking

15:30 Sponsor & investigator oversight

• Workshop

16:00 QA and audit plan

• Organisation

• Obligations

• Tools

17:00 Review of Day 2

17:15 Networking

• Obligations • Tools 17:00 Review of Day 2 17:15 Networking masterclass.registrations@aurelius.in REGISTER ONLINE
• Obligations • Tools 17:00 Review of Day 2 17:15 Networking masterclass.registrations@aurelius.in REGISTER ONLINE

masterclass.registrations@aurelius.in

• Obligations • Tools 17:00 Review of Day 2 17:15 Networking masterclass.registrations@aurelius.in REGISTER ONLINE

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DAY 3

8:30 Protocol deviations and CAPA

• 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

15:50 Panel Discussion Session with our esteemed trainers

• Case Studies brought up by participants

• Panel Discussion

• Q & A Session

• Design your strategy

16:30 Closing remarks from the training leaders

strategy 16:30 Closing remarks from the training leaders sponsor • How to prevent protocol deviations Case

sponsor

• How to prevent protocol deviations

Case studies will be provided for discussion.

deviations Case studies will be provided for discussion. 10:30 Morning Coffee & Networking 11:00 Handling of

10:30 Morning Coffee & Networking

11:00 Handling of Data

• Storage

• Formats

• Pitfalls

11:00 Handling of Data

• Workshop and case studies

12:30 Luncheon

of Data • Workshop and case studies 12:30 Luncheon 13:30 eTMF • Guideline and regulation •Transformation

13:30 eTMF

• Guideline and regulation

•Transformation – paper and electronics

• Storage

•Transformation – paper and electronics • Storage 14:40 Afternoon tea & networking 15:00 eTMF • Workshop

14:40 Afternoon tea & networking

15:00 eTMF

• Workshop & case studies

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REGISTER

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Clinical Trials | 17 th to 19 th September 2019 | Amsterdam, The Netherlands

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In-House TraInIngs

Specific industries face specific problems. They require niche informa- tion and solutions. In-House Training is precisely engineered to your needs.In-House TraInIngs Taking place in the privacy of your company, including real-life case studies and best

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.In-House Training is precisely engineered to your needs. We have the best subject matter experts (empanelled

We have the best subject matter experts (empanelled with us) globally which further help us to draft agenda in line of needs & which is globally which further help us to draft 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 office, interruption of work and duties & incurring travel costs.of needs & which is delivered at the convenient time & venue to you. Do you

Do you need a different topic, venue or date?

the office, interruption of work and duties & incurring travel costs. Do you need a different

ABOUT

AURELIUS

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, with almost 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 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.

60 coun- tries for business before starting this Venture. Insourcing Solutions TRAINING Solutions MASTERCLASSES WE
60 coun- tries for business before starting this Venture. Insourcing Solutions TRAINING Solutions MASTERCLASSES WE
60 coun- tries for business before starting this Venture. Insourcing Solutions TRAINING Solutions MASTERCLASSES WE
60 coun- tries for business before starting this Venture. Insourcing Solutions TRAINING Solutions MASTERCLASSES WE
60 coun- tries for business before starting this Venture. Insourcing Solutions TRAINING Solutions MASTERCLASSES WE

Insourcing Solutions

TRAINING Solutions MASTERCLASSES
TRAINING Solutions
MASTERCLASSES

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 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 and contributions done so far.

Masterclasses is yet another feather in our hat. 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 provide them to the organizations who need it to reach their true potential.