2023-03-24 2023-03-24 , online online, 1,890 € plus tax Jessica Cordes https://www.forum-institut.com/seminar/23032612-clinical-trials-in-a-nutshell-the-european-regulatory-framework/referenten/23/23_03/23032612-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

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 as well as advanced professionals who would like to refresh their regulatory knowledge about GCP will benefit from the seminar.

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).

Your benefit

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.

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 23032612

Book now

JETZT Buchen

Speakers

Everything at a glance

Appointment

23-24/03/2023

23-24/03/2023

Period

Day 1: 09:00 - 17:30Day 2: 09:00 - 1...

Day 1: 09:00 - 17:30
Day 2: 09:00 - 17:00
You may dial in 30 min. before the session

Venue

online

online

Downloads

Fee

Inhouse-offers

Your contact

Clinical trials in a nutshell - Online training

Dr. Tatjana Mende
Conference Manager

+49 6221 500-565
t.mende@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

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 as well as advanced professionals who would like to refresh their regulatory knowledge about GCP will benefit from the seminar.

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).

Your benefit

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.

Detailed programme

Day 1: 09:00 - 17:30
Day 2: 09:00 - 17:00
You may dial in 30 min. before the session

09:15

Dr. Saskia Borregaard

Legal basis

Declaration of Helsinki
ICH Guidelines
National guidelines
Clinical Trials Regulation

10:15

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

11:00 Coffee break

11:15

Prof. Dr Arne Ring

Protocol design = Study Design and Protocol Writing

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

12:45 Lunch break

13:30

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)

14:30

Dr. Saskia Borregaard

Clinical trial application according to EU CTR 536/2014

15:30 Coffee break

15:45

Denise Lee

Clinical Trial Oversight & Monitoring

Sponsor oversight & plan
Vendor management
Monitoring strategy & plan
Metrics & Reporting

16:45

Rommy Schwarz

Data management

What is data?
Data Management Framework & Data Flow
The full process of data management
Systems of data collection
How to obtain data quality
Final steps and the challenge of database locks

17:45

Outstanding questions

Speakers available: -Jessica Cordes -Arne Ring -Saskia Borregaard -Rommy Schaerz

18:00 End of training day I

09:00

Denise Lee

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

Rommy Schwarz

Data integrity

Definitions, regulations and trends
Areas impacted by Data Integrity
Elements of Data IntegrityComputerized systems and Validation paradigm
- Data Integrity Review and audit process

11:45 Lunch break

13:00

Prof. Dr Arne Ring

Statistical Analysis and Clinical Study Report

Data analysis and statistical testing
Multiplicity issues and interim evaluations
Statistical Analysis Plan (SAP)
Protocol deviations, analysis population
Key actions around the database lock
Interdisciplinary interpretation of results

14:00

Martin Hausten

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

Dr. Saskia Borregaard

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.

You will find brief instructions on how to use Zoom, your course documentation, the access link and a meeting ID in your personal customer account.
Use a headset, loudspeakers or the telephone for audio.
Listen to the speaker and follow the presentation.
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

This distinguishes our events

1,7

Overall score of all evaluations in 2022

4,5

Five stars on Trustpilot = Excellent

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