Pharmacovigilance Workshop in Zagreb

In collaboration with HALMED and the Croatian Pharmaceutical Society (HFD)

  • 1. Oct 2018

2 days course

English

300,- EUR ex VAT
(app. 2.231,- DKK ex VAT)

Summary

Dialogue, explanations and clarification

Atrium (former Medicademy) is happy to announce a new pharmacovigilance collaboration in 2018 with Croatian Agency for Medicinal Products and Medical Devices (HALMED) and the Croatian Pharmaceutical Society (HFD). This workshop will address some of the daily challenges within PV, which pharmaceutical companies, CRO, and Regulatory Authorities meet in their everyday work life.

At this PV workshop, you will be updated on the latest news within PV and have the opportunity to discuss challenges with peers and authorities. You will learn about changes to Good Vigilance Practice (GVP) Modules and the influence of EU General Data Protection Regulation (GDPR) in PV.

We will discuss the challenges with Risk Management Plans (RMP), and introduce you to different risk minimization activities.

We will learn about safety collection and reporting in different types of programmes and how to handle safety in digital health activities.

The meeting will have lecturers from different European authorities and the industry, and we will discuss challenges seen both from the perspectives of authorities and industry.

Panel sessions and group work will highlight different challenges and ensure that the audience can take active part in the debate.
 

Keywords

Regulatory update
GDPR in Pharmacovigilance
Risk Management Plans (RMP)
Risk Minimization activities
Organised Safety Data Collection
GVP Inspection
Digital Health Activities & Social Media

  

Reduced Price for Authority/agency employees

Authority/agency employees are offered a reduced price of EUR 160 ex VAT (KUNA 1250 ex VAT)

The price for all other participants is EUR 300 ex. VAT (KUNA 2300 ex VAT)

  

Venue

The Westin Zagreb, Kršnjavoga 1, 10 000, Zagreb, Croatia

What you will learn

  1. Update on the latest pharmacovigilance legislation
  2. How to use good pharmacovigilance practices and how GDPR will influence pharmacovigilance
  3. Inspiration from peers and authorities on how to overcome RMP challenges
  4. How to manage safety in clinical trials, non-interventional studies and other programmes

What your company will get

  1. A safety and pharmacovigilance professional who is updated on the latest pharmacovigilance legislation and other pharmacovigilance related topics
  2. A safety and pharmacovigilance professional who can provide valuable input to other team members
  3. A safety and pharmacovigilance professional who can operate in a dynamic and changing environment
Available start dates

Payment information for PV 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 invoice. We do not provide proforma invoices as a standard.

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

You can pay by credit card or by invoice - The payment terms for invoice is 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 1250 ex VAT). However, on the order confirmation you will see the full price of EUR 300 ex. VAT (KUNA 2300 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 Programme Director Gitte Hornemann Møller at +45 39 15 09 20

Send an email

 

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