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ESC Congress 2020 Register

All About Clinical Trials - EuroCVP 2019

Training course of the Working Group on Cardiovascular Pharmacotherapy

12/12/2019 08:30 13/12/2019 16:00 Europe/Paris All About Clinical Trials - EuroCVP 2019

The European Society of Cardiology Working Group on Cardiovascular Pharmacotherapy is proud to be delivering an engaging and interactive 2 day course to improve the professional knowledge and skills required to plan and deliver successful cardiovascular pharmacotherapy clinical trials. 

Access event page

ESC Working Group on Cardiovascular Pharmacotherapy mailto:workinggroups@escardio.org DD/MM/YYYY
Cardiovascular Pharmacotherapy
In-person
event

Summary

The ESC Working Group on Cardiovascular Pharmacotherapy is proud to deliver an engaging, interactive two-day course to improve the professional knowledge and skills required to plan and deliver successful cardiovascular pharmacotherapy clinical trials. 

Focus on

  • Methodological issues regarding the design, conduct and interpretation of clinical trials
  • New types and trends of trials required by regulators

At the end of the course delegates will have improved their knowledge in:

  • Designing and planning successful clinical trials
  • Evaluating and following the correct processes and regulatory procedures
  • Effectively analysing and interpreting trial data using clinical trials presented at the latest cardiovascular scientific meetings as examples


Course directors

Sven Wassmann, MD, PhD, FESC
Gianluigi Savarese, MD, FESC

Post event resources

SESSION 1. HOW TO DESIGN AND RUN A CLINICAL TRIAL

SESSION 2. REGULATORY ASPECTS

SESSION 3. REGISTRIES and registry-based trials

SESSION 4. ISSUEs IN CLINICAL TRIALS: devices I

WORKSHOP: STATISTICAL ISSUES IN CLINICAL TRIALS I

CLINICAL TRIAL PARADE: WHAT´S NEXT – UPCOMING AND ONGOING CLINICAL TRIALS

ISSUEs IN CLINICAL TRIALS: devices II

WORKSHOP: STATISTICAL ISSUES IN CLINICAL TRIALS II

  • Randomised controlled trials and subgroup analyses: A. Niessner

WORKSHOP: HOW TO INTERPRET CLINICAL TRIAL DATA

WORKSHOP: THINGS TO KNOW FOR JUNIOR INVESTIGATORS

Parallel groups:

Partners

This course is organised in collaboration with the Karolinska Institutet of Stockholm, AIDFM-CETERA Portuguese Academic CRO and the Swedish Cardiac Society.

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Certification in Good Clinical Practice

Each workshop participant is certified in Good Clinical Practice (GCP) after the course.
GCP is an international ethical and scientific quality standard for the design, conduct, and recording and reporting of clinical trials that involve the participation of human subjects. Anyone managing or conducting research in the National Health Service should be aware of Good Clinical Practice and evidence of GCP training is mandatory for gaining Host Site Approval for a Clinical Trial of an Investigational Medicinal Product (CTIMP).

The course provides a review of the fundamentals of Good Clinical Practice. The training is based on the International Conference on Harmonisation GCP guidelines but also introduces The Medicines for Human Use (Clinical Trials) Regulations and Amendment Regulations 2006, which have transposed the EU Clinical Trials Directive. All latest additions are included. The course gives an overview of aspects applicable to all research.

Testimonials

100% of participants would recommend the course to their peers!

“The course allowed me not only to gain a deeper insight into the complex process of organising clinical trials, but it also offered an opportunity to discuss specific methodological pitfalls and interpret the results in cooperation with professionals who represent the highest level of expertise in the field. I highly recommend the course both to experienced investigators and to young researchers, since apart from the conventional aspects of clinical trials methodology; it also presented a novel approach to run the research efficiently and successfully.” Aleksandra Gąsecka, Poland