2020-12-02 2021-12-03 , Online Online, 1.790,- € zzgl. MwSt. Jessica Cordes https://www.forum-institut.de/seminar/2112274-clinical-trials-in-a-nutshell-the-european-regulatory-framework/referenten/21/21_12/2112274-pharma-online-training-course-clinical-trials-in-a-nutshell_cordes-jessica.jpg Clinical trials in a nutshell: The European regulatory framework

All the essentials of clinical trials in Europe in only two days! Six experts will share their in-depth knowledge with you to introduce you as beginner or update you as professional on the most important aspects. Pose your individual questions in advance or live to make the most of your training!

Topics
  • Regulatory framework and current developments
  • You start your clinical trial: What now? - Management at the interfaces
  • Regulatory requirements and interaction with authorities
  • Clinical trial monitoring and quality management
  • Study documentation and document filing
  • Data management, including data integrity and statistical analysis
Aims and objectives
This course imparts broad and practical knowledge about all the essentials of clinical trials in Europe in only two days.
You will acquire the required tools for your daily work with good clinical practice (GCP).

After attending the course, you will
  • be familiar with the major current regulations and guidelines and the regulatory development;
  • be able to assist initiating a new study;
  • understand the structure and content of important study documents;
  • be capable of providing information required for audits and inspections;
  • know about the most important facts regarding data management and statistical analysis;
  • be able to assist in reporting adverse events; and
  • be familiar with the importance of clinical monitoring and quality management.
Who should attend

This two-day training course is aimed at employees in pharmaceutical companies, consultants and contract research organisations.

Both beginners in the field of clinical research will benefit from the seminar contents as well as advanced professionals who would like to refresh their regulatory knowledge about GCP.

Clinical trials in a nutshell - Online training

Clinical trials in a nutshell

- Online training -

Benefits
  • The essentials in only two days
  • Excellent speakers
  • This expertise will benefit your company
  • Pose your individual questions in advance
  • We are following the IMI quality criteria

Webcode 2112274

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Alles auf einen Blick

Termin

02. - 03.12.2021

02. - 03.12.2021

Zeitraum

Day 1: 9:00 am - 5:30 pmDay 2: 9:00 ...

Day 1: 9:00 am - 5:30 pm
Day 2: 9:00 am - 5:00 pm
Veranstaltungsort

Online

Online

Gebühr
Ihr Ansprechpartner

Dr. Birgit Wessels
Conference Manager

+49 6221 500-652
b.wessels@forum-institut.de

Details

All the essentials of clinical trials in Europe in only two days! Six experts will share their in-depth knowledge with you to introduce you as beginner or update you as professional on the most important aspects. Pose your individual questions in advance or live to make the most of your training!

Topics
  • Regulatory framework and current developments
  • You start your clinical trial: What now? - Management at the interfaces
  • Regulatory requirements and interaction with authorities
  • Clinical trial monitoring and quality management
  • Study documentation and document filing
  • Data management, including data integrity and statistical analysis
Aims and objectives

This course imparts broad and practical knowledge about all the essentials of clinical trials in Europe in only two days.
You will acquire the required tools for your daily work with good clinical practice (GCP).

After attending the course, you will

  • be familiar with the major current regulations and guidelines and the regulatory development;
  • be able to assist initiating a new study;
  • understand the structure and content of important study documents;
  • be capable of providing information required for audits and inspections;
  • know about the most important facts regarding data management and statistical analysis;
  • be able to assist in reporting adverse events; and
  • be familiar with the importance of clinical monitoring and quality management.

Who should attend

This two-day training course is aimed at employees in pharmaceutical companies, consultants and contract research organisations.

Both beginners in the field of clinical research will benefit from the seminar contents as well as advanced professionals who would like to refresh their regulatory knowledge about GCP.

Detailed programme

Day 1: 9:00 am - 5:30 pm
Day 2: 9:00 am - 5:00 pm

09:00 Welcome and introductory round


09:15

Simone Völkle

Legal basis
  • Declaration of Helsinki
  • ICH Guidelines
  • National guidelines
  • Clinical Trials Regulation

10:00

Jessica Cordes

Types of clinical trials
  • Phases I - IV
  • Study types: Study designs, blinding, randomization, control groups
  • Differentiation of clinical trials and non-interventional clinical trials

10:45 Coffee break


11:00

Prof. Dr. Hermine Wenzlaff., Dr Max Horneck and Arne Ring

Protocol design
  • Study design: Interdiscip. development
  • Study objective and endpoints
  • Selection of the study population, patient inclusion and withdrawal
  • Visit schedule and assessments
  • Data types, How to obtain the data
  • Statistical planning and test designs
  • Sample size considerations
  • Study disclosure: Register and journals

12:15 Lunch break


13:00

Jessica Cordes

Critical study documentation
  • Study protocol
  • Patient information/Informed Consent Form (ICF)
  • Investigational Medicinal Product Dossier (IMPD)
  • Investigator‘s Brochure (IB)
  • Clinical Study Report (CSR)

14:15

Simone Völkle

Clinical trial application: Regulatory requirements
  • Competent authorities
  • Independent review boards/ethic committees
  • Local regulatory authorities

15:15 Coffee break


15:30

Prof. Dr. Hermine Wenzlaff

Clinical trial monitoring
  • Monitoring plan
  • Extent and nature of monitoring: On-site, remote, centralized
  • Monitoring responsibilities, reporting

16:35

Dr Max Horneck

Data integrity and computerised systems
  • Why data integrity (DI) matters
  • Lifecycle of data, risks for DI
  • A small toolkit for DI
  • Living a culture of DI

17:15 Outstanding questions


17:30 End of training day I


09:00

Henrieke de Bie

Clinical quality management
  • Critical data and processes
  • Risk assessment
  • Standard Operating Procedures (SOPs)
  • Audits and inspections

09:45

Henrieke de Bie

Clinical safety management/pharmacovigilance
  • (Serious) Adverse events
  • (Emergency) unblinding
  • Medical monitoring
  • SUSARs and (further) safety reporting to regulatory authorities and ethics committees
  • New safety signals and urgent safety measures
  • Safety updates (incl. DSUR)

10:45 Coffee break


11:00

Dr Max Horneck

Data management
  • Recap: Collection of data
  • The full process of data management
  • Planning, planning and planning
  • Systems of data collection
  • How to obtain data quality
  • Final steps and the challenge of database locks
  • Case Report Form (CRF)

12:00 Lunch break


13:00

Arne Ring

Statistical analysis
  • Data analysis and statistical testing
  • Sources of bias
  • Multiplicity issues and interim evaluations
  • Missing data, compensation strategies
  • Components and development of the Statistical Analysis Plan (SAP)
  • Protocol deviations, analysis population
  • Key actions around the database lock
  • Interdisciplinary interpretation of results

14:00

Henrieke de Bie

Trial document filing
  • Essential documents
  • Trial Master File (TMF)
    • Sponsor files
    • Investigator site file
  • TMF organisation, control and integrity of records/data
  • Document retention and archiving

15:00 Coffee break


15:15

Simone Völkle

Case study: Tips and tricks during study start up
  • IMP
  • Feasibility & start-up activities
  • Regulatory strategy
  • Feedback from regulatory authorities
  • Clinical trial in maintenance

16:15 Wrap-up and concluding discussion


17:00 End of training


More information

How does an online seminar work?

Our online training courses are live and interactive. They are held and controlled directly by our speaker. You may take part in the seminar from anywhere using your end device. You will see the presentation and listen to our speaker's lecture using Internet telephony (VoIP) or even a normal telephone connection. And you can also ask questions live.

1. You will receive brief instructions on how to use Zoom beforehand.
2. 48 hours before the online seminar, you will receive an email with an access link and a meeting ID.
3. Use a headset, loudspeakers or the telephone for audio.
4. Listen to the speaker and follow the presentation.
5. Feel free to switch from silent to audio mode by yourself any time to ask your questions.

The benefits of an online seminar

  • Attend the training in all comfort, from wherever you like
  • There are no travel and accommodation costs
  • Ask questions live whenever you desire

Send us your individual questions

Please send us your questions concerning the seminar topics in advance.

We will be happy to forward them to the speakers, so that they know about your training requirements even better and are able to answer your questions at the seminar.

Please send your questions to b.wessels@forum-institut.de

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Overall score of all evaluations in 2020

Five stars on Trustpilot = Excellent

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