GCP & CTR Workshop in Zagreb, Croatia

Dialogue, Explanations and Clarification

  • 25. Nov 2019
  • 25. Nov 2019
  • 26. Nov 2019

2 days course

English

200,- EUR ex VAT
(app. 1.488,- DKK ex VAT)

Summary

Atrium is happy to announce a 3rd Workshop in Croatia. This year we will focus on Good Clinical Practice & Clinical Trial Regulation. The workshop is a collaboration between Atrium and various Croatian governmental and non-governmental stakeholders.

Day 1: GCP (Good Clinical Practice) - 25 November 2019
On day one, you will get updated and (re)certified within ICH-GCP. The integrated addendum (E6) came into effect on June 14, 2017. The addendum provides additional recommendations to facilitate innovative approaches to GCP to better ensure data quality and human subject protection in an environment of highly complex multinational trials.

Day 2: CTR (Clinical Trial Regulation) - 26 November 2019
On day two, we will look into the process and consequences of the EU Clinical Trial Regulation, currently expected to come into force in 2020. We will address implementation challenges, future clinical trial application processes, public access to clinical data, and the possible impact on the work of clinical trial professionals.

There are several options for joining this seminar: You can buy a full ticket for both day 1 and day 2, or you can buy a one-day ticket for either day 1 or day 2. Please choose your ticket when you register. 

Price for full ticket (2 days):
Authority/agency employee EUR 160 ex VAT
Industry employee EUR 300 ex VAT

Price for one-day ticket:
Authority/agency employee EUR 105 ex VAT
Industry employee EUR 200 ex VAT

 

Keywords

Good Clinical Practice  (GCP) 
Update and (re)certification within ICH-GCP 
Innovative approaches to GCP
Ensuring data quality and human subject protection in complex multinational trials 
Clinical Trial Regulation (CTR)
Process and consequences of the EU CTR
Implementation challenges
Future clinical trial application processes
Public access to clinical data
Impact on the work of clinical trial professionals

What you will learn

  1. Get updated and (re)certified within ICH-GCP
  2. Get an understanding of innovative approaches to GCP
  3. How to better ensure data quality and human subject protection in an environment of highly complex multinational trials
  4. An understanding of the process and consequences of the EU CTR
  5. Awareness of the EU CTR implementation challenges
  6. An understanding of the impact the EU CTR will have on the work of clinical trial professionals

What your company will get

  1. An employee who is correctly certified within ICH-GCP in accordance with EU requirements
  2. An employee who will be able to facilitate innovative approaches to GCP to better ensure data quality and human subject protection in complex multinational trials
  3. An employee on top of the process and consequences of the EU CTR
  4. An employee who is able to address and handle implementation challenges of the EU CTR
  5. An employee who will understand the impact that the EU CTR will have on the work of clinical trial professionals and therefore can adjust processes accordingly
Available start dates
All course dates: 25. Nov 2019, 26. Nov 2019
All course dates: 25. Nov 2019
All course dates: 26. Nov 2019

Payment Information for Clinical Workshop in Zagreb

After registering for the course, you will receive an order confirmation and when we have confirmed your registration, we will send an Proforma Invoice. The original invoice will be issued after the event.

If you register more participants at one time, you will get one overall Proforma Invoice on the course fees. 

Notice, the Proforma Invoice will only be emailed to the first registered participant.

You can pay by credit card or by Proforma Invoice - The payment terms for Proforma Invoice is 30 days from Proforma Invoice date.

You can see our vendor information here: 

Full Company Name: DLI - Dansk Laegemiddel Information A/S 
Address: Lersoe ParkAllé 101 
ZIP Code: 2100 
City: Copenhagen 
Country: Denmark 
Telephone number: 0045 39274488 
VAT number: DK1747 2682 
IBAN EUR: DK5830004316089798 
Bank account no.: 4316-4316089798 
BIC code/SWIFT code: DABADKKK 
Bank name: Danske Bank 

Please note that our payment policy is that all our customers must pay within 30 days from invoice date. 

If you register with a Croatian VAT number payment is charged from our Danish VAT number (DK 17472682) with reversed charge (0% VAT).

If you register with a non-Croatian VAT number payment is charged from our Croatian VAT number (HR 88832862375).

When you register as an authority/agency employee you will get the reduced price of EUR 160 ex VAT (KUNA 1190 ex VAT) = 2 day workshop or . However, on the order confirmation you will see the full price of EUR 300 ex. VAT (KUNA 2225 ex VAT).

We will only charge the reduced price of EUR 160 ex VAT (KUNA 1250 ex VAT), which will appear on the invoice.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Director Søren-Ulrik Fangholm at +45 39 15 09 45

Send an email

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