4th Annual Pharmacovigilance Forum
29-30 September 2016

NH Berlin Mitte – Berlin – Germany

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

Managing Director – Astellas Pharma Europe – The Netherlands

Discover the hot topics

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

Check the schedule and request your detailed agenda

Day one

  • 08:30 Welcome Coffee and Registration
    08:45 Greeting from the Project Leader & GLC Icebreaker Session
    08:50 Opening Remarks from the Chair

    09:00 New regulations on the horizon

  • 09:40 Best practices in the field of PSMF

  • 10:50 The evolution of the chief safety officer role and the safety organization of tomorrow

  • 11:30 Audits and inspections

  • 12:10 Audits conducted by business partners

  • 14:30 Benefit-Risk Evaluations: The patient perspective

  • 15:10 ADE and ADR reporting from a hospital pharmacist’s perspective

  • 16:20 Implementation of risk-minimizations measures

  • 17:00 Practical aspects in the preparation of the PBRER

Day two

  • 09:00 PRAC updates

  • 09:40 Incorporating a patient centric approach to help improve patient safety

  • 10:20 Value or volume?

  • 11:30 Patient support programs

  • 12:50 Studies for risk management: approached and challenges

  • 14:30 Implementation and evaluation of medicines authentication system in second care

  • 15:50 Mitigate the costs of PV- PV Outsourcing

Get insight into a similar past event

Get to know our renowned speakers

Become a speaker
Karsten Lollike
Karsten Lollike Corporate Vice President
Novo Nordisk A/S
Denmark
Doris Irene Stenver
Doris Irene Stenver Member of the Pharmacovigilanc Risk Assessment Committee
(PRAC) at European Medicines Agency (EMA)
Denmark
Professor Saad Shakir
Professor Saad Shakir Director
Drug Safety Research Unit
United Kingdom
Giovanni Furlan
Giovanni FurlanEU QPPV
Helsinn Birex Pharmaceuticals
Ireland
Bert Van Leeuwen
Bert Van LeeuwenDeputy Qualified Person for Pharmacovigilance (QPPV)
Astellas Pharma Europe
The Netherlands
Heike Schoepper
Heike SchoepperHead Global Drug Safety Regions
Merck Serono
Germany
David Brindley
David Brindley Research Fellow
Oxford University/ Harvard University
United Kingdom
 Rudi Scheerlinck
Rudi Scheerlinck Head Global Drug Safety
Basilea
Switzerland
Joan Francesc Aregall Picamal
Joan Francesc Aregall PicamalFormer Pharmacovigilance Country Head
Bayer
Spain
Emanuel Lohrmann
Emanuel LohrmannLead Safety Physician
Boehringer Ingelheim
Germany
Juhaeri Juhaeri
Juhaeri JuhaeriVice President and Head, Global Safety Sciences
Sanofi
United States of America
Jukka Pesonen
Jukka PesonenDirector, Drug Safety (QPPV)
Orion Pharma
Finland
 Barbara Del Carlo
Barbara Del CarloHead of Global Pharmacovigilance Operations, Deputy QPPV
Chiesi
Italy
Hermone Berhane
Hermone BerhaneHead, Operations Vendor Management
Roche
United Kingdom
Barbara Claus
Barbara Claus Visiting Professor Pharmacoeconomics
Ghent University
Belgium
 Susan Welsh
Susan Welsh Chief Safety Officer
Sanofi
France
Monika Manske, Dr. (PhD)
Monika Manske, Dr. (PhD)Associate Director, Global Pharmacovigilance Governance Head Pharmacovigilance Quality System
Mylan
Germany
Ulrich Vogel
Ulrich VogelHead, Strategic Data Analysis, Global Pharmacovigilance
Boehringer Ingelheim
Germany
Howard Snow
Howard SnowTherapy Area Safety Leader, Ophthalmology/ Pharmacovigilance Group Head
Novartis
Switzerland

6 more reasons to attend

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 participation in the event. Cancellation must be received by GLC in writing, either by 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.
  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.