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Speakers

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Doris Irene Stenver
Doris Irene StenverMember of the Pharmacovigilance
Risk Assessment Committee (PRAC) at European Medicines Agency (EMA)
Denmark
Aleksandra Martinovic
Aleksandra MartinovicFormer Head of Pharmacovigilance
Austrian Agency for Food and Drug Safety(AGES)
Austria
Karsten Lollike
Karsten LollikeCorporate Vice President
Novo Nordisk A/S
Denmark
Rudi Scheerlinck
Rudi ScheerlinckHead Global Drug Safety
Basilea
Switzerland
David Brindley
David BrindleyResearch Fellow
Oxford University/ Harvard University
United Kingdom
Vincent Jullien
Vincent JullienGlobal Head of Pharmacovigilance, EU QPPV
Guerbet
France
Giovanni Furlan
Giovanni FurlanEU QPPV
Helsinn Birex Pharmaceuticals
Ireland
Daniela Miltner
Daniela MiltnerProduct Manager
EXTEDO
Germany
Heinz Weidenthaler
Heinz WeidenthalerDirector Pharmacovigilance, QPPV
Bavarian Nordic
Germany
Shreya Davé
Shreya DavéDirector, Pharmacoepidemiology
Takeda Pharmaceuticals Europe
United Kingdom
Anca Miclea
Anca MicleaSenior Specialist Medical Safety & Epidemiology
Abbott Laboratories
Germany
Matthias Heck
Matthias HeckHead of Brussels office
German Pharmaceutical Industry Association (BPI)
Belgium
Anne Gramkow
Anne GramkowHead of Safety and QPPV
Pharmacosmos
Denmark
Aleksei Babich
Aleksei BabichAssociate Director Global Drug Safety Benefit-Risk Management
Grünenthal
Germany
Phillip Eichorn
Phillip EichornSenior Director
Pfizer
United Kingdom
Professor Saad Shakir
Professor Saad ShakirDirector
Drug Safety Research Unit
United Kingdom
Ioan Magyar
Ioan MagyarAssoc.Prof. of Basic & Clinical Pharmacology Faculty of Medicine & Pharmacy
Oradea University
Romania
Manfred Hauben
Manfred HaubenSenior Director, Risk Management Strategy
Pfizer Inc
United States
Bert Van Leeuwen
Bert Van LeeuwenDeputy Qualified Person for Pharmacovigilance (QPPV)
Astellas Pharma Europe
The Netherlands
Elvira Falco
Elvira FalcoHead of Regulatory and Pharmacovigilance
Eli Lilly
Spain
Pipasha Biswas
Pipasha BiswasDir., CPD (Continuing Professional Development) Faculty of Pharmaceutical Medicine
The Royal College of Physicians
United Kingdom
Peter De Veene
Peter De VeeneExecutive Director, Clinical Safety and Pharmacovigilance
Daiichi Sankyo
United Kingdom

Advisors

Karsten Lollike
Karsten LollikeCorporate Vice President
Novo Nordisk A/S
Denmark
Bert Van Leeuwen
Bert Van LeeuwenDeputy Qualified Person for Pharmacovigilance (QPPV)
Astellas Pharma Europe
Netherlands
Tatjana Ajhler Duretek
Tatjana Ajhler DuretekHead of Medical Affairs and Pharmacovigilance
Belupo Pharmaceuticals & Cosmetics Inc.
Croatia
Teresa Herdeiro
Teresa HerdeiroPharmD PhD Health Sciences
Department
University of Aveiro Portugal
Zsuzsanna Müller
Zsuzsanna MüllerPharmacovigilance Manager
CSC Pharmaceuticals Handels GmbH
Austria

Schedule

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DAY ONE

  • 9:00 - 9:40 Regulatory Highlights
  • 9:40 - 10:20 Quantitative Methods in Pharmacovigilance
  • 12:40 - 13:20 Outsourcing in Pharmacovigilance
  • 17:30 - 18:10 Risk Management Plans (RMPs)

DAY TWO

  • 9:40 - 10:20 Updates from PRAC
  • 13:10 - 13:50 Communication with the Public in PV
  • 13:50 - 14:30 Social Media, Apps and Networks in PV
  • 16:20 - 17:00 Globalisation of PV

6 reasons to attend

What do others say about us?

testimonials_Trans_photo
“I find it very nice for me as I’ve made
some very interesting new contacts
of targeted group. ”

Licensing Manager, Springer
testimonials_Trans_photo

“I think it has been very interesting to participate.
I always like to meet colleagues in the field
because you can be aware of
what is on top of mind in the industry.”
Chief Medical Officer
Danish Health and Medicine Authority

TICKETS

Who will you meet?

Senior Pharmacovigilance Regulators and Inspectors, Pharmacovigi¬lance and Drug Safety Officers, Regulatory Affairs Officers, Clinical Risk-Benefit Groups, Local Medicines Authorities, CRO and Consul¬tants providing QPPV Services, Pharma Industry Heads, Directors and Managers OF:

  • Compliance
  • Drug Safety
  • Global Drug Safety
  • Heads of Safety and Pharmacovigilance Inspection and Audit
  • International PV Auditors
  • Lead Safety Scientists
  • Medical Affairs
  • Patient Safety
  • Pharmacoepidemiology
  • Pharmacovigilance Consultants
  • Pharmacovigilance
  • PSMF
  • PV Quality System
  • QPPV Personnel’s
  • Regulatory Affairs
  • Safety & Risk management
  • Safety Evaluation
  • Safety Specialists
  • Safety Surveillance
  • Signal Detection

Media partners

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Clients

Venue

Venue

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FAQ

You can always register without a name using the TBA [To Be Announced] option. Please indicate TBA instead of the delegate name and 2 weeks prior to the event you are able to send the delegate name/s to booking[at]glceurope.com
While we are not happy to see you cancel your registration, we understand that “life happens” and other obligations come up. Our refund schedule is as follows:
The client has the right to cancel his/her participation in the event. Cancellation must be received by GLC in writing, either by e-mail or fax. If the client cancels with more than one month’s advance notice before the start of the event, GLC shall be entitled to retain 50% of the amount for participation in the event [minimum of €1198 per delegate]. If the client cancels with one month’s [or less] advance notice, or fails to attend the event, then the client shall not be entitled to any refund. Failure to attend an event shall not excuse a client from owing the full amount of the registration fee. A copy of the conference notes from the event will be sent to the client after the event is over in case of cancellation by the client.
In general no VAT is applied based on the Hungarian VAT law with the exception of individual payment [when you would like to pay from your own budget and not from the company’s budget] and for Hungarian companies where 27% VAT is applicable which is refundable at the end of the company’s fiscal year.
Our hospitality partners usually have options available for parking places, however it can change from event to event. If you would like to receive more information on parking please e-mail our colleague lara.ventoso[at]glceurope.com.
We provide a conference documentation pack which includes: conference agenda, notes pages and attendee information. Soft copies of some of the presentation are available on USB-flash-drives for each delegate. You may bring your laptop, tablet or other mobile device so you are able to review the presentations while they are being presented. Free Wi-Fi will be provided and outlets will be available for recharging computers, mobile devices and phones. We highly recommend you to bring along your business cards and a desire to learn from some of the industry’s leading experts.
The dress code is business casual. Feel free to leave the suits and ties at home this time. We do suggest you bring a sweater or dress in layers, as the conference room temperature may fluctuate.
Any of our staff members at the event will be delighted to help you. You can contact us for free via WhatsApp or Viber or any time over the phone or via e-mail or post.
A. Get the timing right.
Many people are afraid to request for training budget, because they can’t seem to find the “perfect time” to do it. Well, there’s no perfect time to ask for it, but there are definitely some moments that are better than others. For instance, if your boss is about to take a two week vacation, he/she might be in a good mood. If he/she just lost a major account, may not be wise at that juncture.

B. Make a case for yourself
When you ask for budget, you should be prepared with specific details and explanations about what is in it for the company and you’re superior. If you go into a meeting and just say, “I want to get budget for a conference,” it’s likely that your request won’t be taken seriously. If you want to plan ahead, then you should be prepared to explain the following points:
1. Start by stating your accomplishments
2. Show that you’re ready for more responsibility and eager to learn
3. Describe:
a) How this event will increase your productivity?
b) How you will need less supervision
c) How you can bring back the knowledge to the company
4. Follow up

You might find free to attend events which are usually organized by a solution/service provider within the industry. Unlike at free to attend events, on a paid event you will find more diverse industry knowledge rather than presentations related to services or solutions.
In case you cannot attend for both days, you can always attend for just 1 day of the event. In this case we will send you all presentations of the 2 days. The participation fee is 70% of the original investment. In case you would like to attend the event for just 1 day please contact us on booking[at]glceurope.com
In case you are busy on 1 of the days, you certainly can split the 2 day conference with one of your colleague. All you need to do is send us an e-mail to booking[at]glceurope.com
We understand that not all senior-level professionals might be available on the dates. As the event is an annual event, most of the attendees try to postpone their engagements or send a small group from their teams to benefit from the conference.