5th Annual Pharmacovigilance Forum
02-03 March 2017

Crowne Plaza Potsdasmer Platz – Berlin – Germany

“Conference with much, well-varied, Pharmacovigilance relevant subjects presented by experts.”

Managing Director – Astellas Pharma Europe – The Netherlands

Request detailed Agenda - 5th Annual Pharmacovigilance Forum
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5th Annual Pharmacovigilance Forum

In such turbulent times, pharmacovigilance has been also affected by the unexpected changes of the World. BREXIT and Trump tornado, what else to come? In order to stay up-to-date our 5th Annual Pharmacovigilance Forum is a perfect opportunity to hear the most important updates of the industry. We bring together the top minds of the pharmaceutical industry from all over Europe to share their experiences and best practices and to network with their peers. Topics such as BREXIT vs. Pharmacovigilance, effectiveness evaluation of risk minimization measures, signal detection and Eudravigilance, GVP guidance, significance of outsourcing and many more will be discussed and consulted during our event. For those interested in Biosimilars Dr. Niraj Chhaya from Boehringer Ingelheim GmbH will present the success factor of biosimilars.

We are also happy to welcome Andrew A. Parsons on board from Reciprocal Minds Limited who will talk about human factors in Pharma R&D. This is a special feature to the event which will be a great added value to the audience.
Stay up-to-date and join our upcoming event to meet these leaders of the industry and listen their inspiring presentations in order to take home the most beneficial outcome for you and your company.

Discover the hot topic

You can credit training/learning hours towards your professional accreditation by participating on this CPD certified forum.

For detailed program request the agenda

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Event schedule

Day one

  • 08:30 Welcome Coffee and Registration

  • 09:00 Pharmacovigilance in the light of BREXIT

  • 09:40 Switzerland- still a special country; Tips for an successful Pharmacovigilance Inspection

  • 10:20 Web-based signal detection

  • 11:00 Tea, Coffee, Networking & Exhibits

  • 11:30 Current regulatory trends in PASS and PIP studies

  • 12:10 Effectiveness Evaluation of Risk Minimization Measures: a Case Study

  • 12:50 Luncheon & Networking

  • 13:50 Reclassifying medicines for OTC: Assessing benefit-risk and risk minimization in a consumer setting

  • 14:30 Practical advice on the planning and conduct of Pharmacovigilance audits in small and medium-sized enterprises (SMEs)

  • 15:10 Tea, Coffee, Networking & Exhibits

  • 15:40 Why does pharmacovigilance sometimes fail and where could the fault lie?

  • 16:20 Human Factors – Optimising the usability of processes and technology in Pharma R&D

  • 17:00 Pharmacovigilance of Antibiotics

  • 17:40 Closing Remarks from the Chair & Networking

Day two

  • 08:30 Meet, Greet & Networking with Welcome Coffee

  • 09:00 Signal Detection an Eudravigilance

  • 09:40 Pharmacovigilance : The patient Perspective

  • 10:20 Safety aspects of Patient Support Programmes and other Customer Engagement Activities

  • 11:00 Tea, Coffee, Networking & Exhibits

  • 11:30 Signal Management – revised GVP guidance

  • 12:10 Connection between counterfeit medicines and
    pharmacovigilance

  • 12:50 Luncheon & Networking

  • 13:50 Pharmacovigilance for Biosimilars

  • 14:30 Significance of outsourcing and its effectiveness

  • 15:10 Tea, Coffee, Networking & Exhibits

  • 15:40 Safety Alerts: An Observational Study in Portugal

  • 16:10 Medical literature monitoring

  • 16:40 Closing Remarks from the Chair & Farewell Networking

Get insight into a similar past event

Get to know our renowned speakers

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Shreya Davé
Shreya DavéDirector, Pharmacoepidemiology
Takeda Pharmaceuticals Europe
United Kingdom
Dr. Maria Teresa Herdeiro
Dr. Maria Teresa HerdeiroProfessor, Director of Diagnosis and Therapeutic Technologies Department
University of Aveiro
Portugal
Souzi Makri
Souzi MakriPresident/ Chairperson/ Fellow
ENFA/AGORA/EUPATI
Cyprus
Dr. Steinar Madsen
Dr. Steinar MadsenMedical Director, Department of Drug Information
Norwegian Medicines Agency
Norway
Bert Van Leeuwen
Bert Van LeeuwenDeputy Qualified Person for Pharmacovigilance (QPPV)
Astellas Pharma Europe
The Netherlands
Amer Alghabban
Amer AlghabbanVice President GxP Quality Assurance, Compliance Training
Karyopharm Therapeutics
Switzerland
Mariska Kooijmans-Coutinho
Mariska Kooijmans-Coutinho Head of Drug Safety and Pharmacovigilance International and EU QPPV
Amicus Therapeutics
United Kingdom
Katalin Tímár - Horváth
Katalin Tímár - HorváthManaging Director
ComFit Europe Ltd
Hungary
 Rudi Scheerlinck
Rudi Scheerlinck Head Global Drug Safety
Basilea
Switzerland
Juhaeri Juhaeri
Juhaeri JuhaeriVice President and Head, Global Safety Sciences
Sanofi
United States of America
 Susan Welsh
Susan Welsh Chief Safety Officer
Sanofi
France
Dr. Belal Naser
Dr. Belal NaserHead of Pharmacovigilance | QPPV
Schaper & Brümmer
Germany
Andrew A. Parsons
Andrew A. ParsonsExperienced Scientist, Executive Leader, Coach, Trainer and Supervisor. Co-author of Leading with Presence
United Kingdom
Bawan Ahmed
Bawan AhmedMember of National Drug Policy expert committee
Kurdistan Regional Government
Antonella Bacchieri
Antonella BacchieriMember of National Drug Policy expert committee
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
Italy
Mircea Ciuca
Mircea CiucaHead Medical & Clinical Drug Safety
Vifor Pharma
Switzerland
Dr. Niraj Chhaya
Dr. Niraj ChhayaRisk Management, Global Pharmacovigilance Biosimilar Portfolio
Boehringer Ingelheim GmbH
Germany
Dr. Eric Teo
Dr. Eric TeoHead of Pharmacovigilance
Sanofi
France
Khaudeja Bano
Khaudeja BanoSenior Medical Director, Medical Device Safety Head
AbbVie
United States of America

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Past Sponsors

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Who will you meet?

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

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

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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 registration in the event.
There is a 50% liability on all conference registrations once made, whether the booking was made through our website or via e–mail/ telephone/ fax.
If the client cancels with more than 8 weeks’s advance notice, GLC shall be entitled to an amount equivalent to 50% of the conference fee and 16 EUR administration charge. In case the client has already made his/her payment, this will be deducted from the conference fee GLC has already received and the remainder will be refunded. If no conference fee has been received prior to the cancellation request, GLC will issue an invoice for the cancellation fee (the amount equivalent to 50% of the conference fee and 16 EUR administration charge), which the client must pay immediately upon receipt. No refunds are available for cancellations received with 8 week’s (or less) advance notice or in case the client fails to attend the conference. In these cases, the full amount of the conference fee must be paid.
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 susanna.juhasz[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.
  1. 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.
  2. 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.

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