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All About Clinical Trials - EuroCVP

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

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. 

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

This course is an excellent opportunity for education and networking.

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.

Programme

The course will start at 08h30 on 12 December, and end on 13 December around 16h00.

All About Clinical Trials: Day 1 (Sessions and GCP Course)

Time

Title

REGISTRATION

8:30

Welcome, introduction and course objectives: S. Wassmann, G. Savarese

8:35

The ESC Working Group on Cardiovascular Pharmacotherapy - Perspectives of a Past-Chairman and Editor-in-Chief: S. Agewall

SESSION 1. HOW TO DESIGN AND RUN A CLINICAL TRIAL

8:45

An overview of the different aspects of clinical trials: G. Savarese

9:15

Planning and running a clinical trial: site perspective: B.S. Lewis

9:45

Traditional versus novel trial designing: J. Tamargo

SESSION 2. REGULATORY ASPECTS

10:15

Requirements from regulatory agencies and post marketing surveillance: G.M.C. Rosano

10:45

Refreshments and networking

SESSION 3. REGISTRIES and registry-based trials

11:00

SWEDEHEART and registry-based trials in ischemic heart disease: S. James

11:30

SWEDE-HF and registry-based trials in heart failure: L. Lund

12:00

Danish nationwide registries and cohort studies: C. Torp-Pedersen

12:30

Lunch and networking

SESSION 4. ISSUEs IN CLINICAL TRIALS: devices I

13:30

ICD trials: F. Braunschweig

COURSE: GOOD CLINICAL PRACTICE

14:00

GCP for the busy investigator (certificate included): I. Cabrita - AIDFM-CETERA Portuguese Academic CRO

16:00

Close of day 1

 

All About Clinical Trials: Day 2 (Sessions and Interactive Workshops)

8:30

Welcome and objectives: S. Wassmann, G. Savarese

WORKSHOP

8:35

WORKSHOP: STATISTICAL ISSUES IN CLINICAL TRIALS I

·       Registries and meta-analyses: G. Savarese

10:00

Refreshments and networking

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

10:30

ACS / Antithrombotics: S. Wassmann

10:45

Lipidology: B.S. Lewis

11:00

Diabetes: H. Drexel

11:15

Heart failure: C. Ceconi

ISSUEs IN CLINICAL TRIALS: devices II

11:30

CRT trials: C. Linde

12:00

Lunch and networking

WORKSHOPS

13:00

WORKSHOP: STATISTICAL ISSUES IN CLINICAL TRIALS II

·       Randomised controlled trials and subgroup analyses: A. Niessner

14:30

Refreshments and networking

14:45

WORKSHOP: HOW TO INTERPRET CLINICAL TRIAL DATA

Examples from clinical trials: S. Wassmann, Panelists

15:30

WORKSHOP: THINGS TO KNOW FOR JUNIOR INVESTIGATORS

Parallel groups:

·       How to write a manuscript: A. Semb

·       Career Café: speed consultations: G.M.C. Rosano

15:55

Closing remarks: S. Wassmann, G. Savarese

16:00

Close of day 2

Registration

Registration fees

  • Young Members fee (Working Group and/or Swedish Society of Cardiology Members under 40 years old): 50€
  • Members Fee (Working Group and/or Swedish Society of Cardiology Members): 100€
  • Standard fee: 300€

Not member of the Working Group yet? Join now

Register now

What your registration includes

Your registration fee includes:

- Access to the two days of teaching course

- Certification in Good Clinical Practice

Your registration fee does not include:

- Travel & accommodation

- Any other expenses

Venue

The course will be held at the Elite Karolina Tower Hotel, in Stockholm, Sweden.

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