GLC Europe

3rd Annual Pharmacovigilance Forum

3rd Annual Pharmacovigilance Forum

Industry: Pharmaceutical
Date: 17-18 September 2015
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Event Summary

Visionary pharmacovigilance experts across the world are eager to develop a new global network, to share benefit and risk based intelligence of medicinal products. With the fast spread of globalisation, cross-borders & trade-blocs, medical practitioners and drug manufacturers are force to adopting holistic strategies to battle the increasing pressure from their stake holders. The humble aim of GLC’s 3rd Annual Pharmacovigilance Forum, is to provide a platform for these practitioners in the hope of finding the answers to some of the pressing issues they face nowadays.        

Be the first to uncover the first experiences of complete transition from DDPS to PSMF. Listen to industry experts discussing ready-made and tested solutions to transparency issues in ADR. Discover the correct directions, to adhere to upcoming regulatory deadlines, discussed by its creators, if not by its supporters. Witness the highlight of the event, a participative workshop providing practical insights to overcome inefficiencies and redundancies in PV processes. Meet and greet 20+ industry specialists from global conglomerates such as, Novartis, Pfizer, Abbott, Astellas, Takeda and other experts from the European Medicines Agency, The Royal College of Physicians, and the Drug Safety Research Unit surrounded by a selected senior audience from across Europe.    

Coupled with a diversified set of thought leaders and a five star environment, this one of a kind symposium, will link drug manufacturers with the medical practitioners, academia’s, PV related associations and governmental representatives from across Europe under one roof.Without a doubt, an exclusive gathering within the PV event space, you cannot afford not to capitalise upon.      


Key Takeaways
  • Regulatory overview of the past year and forecast for 2015
  • Essential updates on the current situation of PRAC
  • Understanding regulatory requirements for the Pharmacovigilance System Master File (PSMF)
  • Solutions to Improve and maintain Pharmacovigilance System Master File (PSMF) in practice
  • Principles of the Risk Management Plan and best practice in risk mitigation
  • Advantages and disadvantages of outsourcing in the pharmaceutical industry
  • Emerging IT Solutions to enhance Pharmacovigilance System
  • Investigate what is required for a Post-Authorisation Safety Studies (PASS) and Post- Authorisation Efficacy Studies (PAES)
  • Pitfalls of ADR data collection and management
  • Adaption of real World Evidence in Pharmacovigilance and Drug Safety
  • Challenges of the recently launched Black Triangle Symbol
  • General principles of writing and submitting Periodic Safety Update Reports (PSUR)
  • Strategies to overcome the challenges of Qualified Person for Pharmacovigilance (QPPV)
  • Investigate the  impact of the new EU requirement on QPPV role
  • Key issue: communication with the patients
  • Path of challenges towards the optimal signal detection 
  • Importance of monitoring in the industry

Speaker Panel

Doris Irene Stenver
Member of the Pharmacovigilance Risk Assessment Committee
European Medicines Agency
Susana Goncalves
Sr. Pharmacovigilance Leader
Karsten Lollike
Corporate Vice president
Novo Nordisk A/S

Vincent Jullien
Global Head of Pharmacovigilance, EU QPPV

Bert Van Leeuwen
Deputy Qualified Person for Pharmacovigilance (QPPV)
Astellas Pharma Europe

Giovanni Furlan
Helsinn Birex

Anca Miclea
Senior Specialist Medical Safety & Epidemiology
Abbott Laboratories

Raquel Rogers
Safety Risk Lead
United Kingdom

Heinz Weidenthaler
Director Pharmacovigilance, QPPV Bavarian

Professor Saad Shakir
Drug Safety Research Unit
United Kingdom

Ioan Magyar
Assoc.Prof. of Basic & Clinical Pharmacology
Faculty of Medicine & Pharmacy
Oradea University

Nele Matthijs
Pharmacovigilance inspector

Shreya Davé
Director, Pharmacoepidemiology
Takeda Pharmaceuticals Europe
United Kingdom

Peter De Veene
Executiv Director
Clinical Safety and Pharmacovigilance
Daiichi Sankyo
United Kingdom

Matthias Heck
Head of Brussels Office
German Pharmaceutical Industry Association (BPI)

Anne Gramkow
Head of Safety and QPPV

Prestigious Advisors

Karsten Lollike
Corporate Vice President
Novo Nordisk A/S

Bert Van Leeuwen
Deputy Qualified Person for Pharmacovigilance (QPPV)
Astellas Pharma Europe

Tatjana Ajhler Duretek
Head of Medical Affairs and Pharmacovigilance
Belupo Pharmaceuticals & Cosmetics Inc.

Teresa Herdeiro 
PharmD, PhD Health Sciences Department,
University of Aveiro

Zsuzsanna Müller
Pharmacovigilance Manager
CSC Pharmaceuticals Handels GmbH

Who Should Attend
Members of the Board, Managing Directors, Vice Presidents, Directors, Heads, Global and International Managers of :
  • Pharmacovigilance 
  • Drug Safety 
  • Risk Management & Surveillance  
  • Clinical Safety  
  • Pharmacoepidemiology 
  • Post Authorization Safety  
  • Qualified Person 
  • Data Management 
  • Research & Development 
  • Patient Safety 
  • Regulatory Affairs
  • Medical Information 
  • Medical Affairs 
  • Signal Detection 

Venue Information
Vienna, the so-called “city of dreams” is the capital of Austria. Situated on the banks of the Danube, it offers a wonderful experience to its visitors from all over the world. Known for its rich history, its remarkable cultural attractions and its vast sightseeing possibilities, it is one of the most beautiful places in Central Europe. Its atmosphere also boasts the comforts and infrastructure of a modern city. This charming European gem has been named the best place to live in the world on numerous occasions.

10 must-visits in Vienna
Schönbrunn Palace and Gardens
Vienna State Opera House
Hofburg Imperial Palace
The Rathaus
St. Stephen’s Cathedral
Church of St. Charles Borromeo
The Kunsthistorisches Museum
The Leopold Museum
The Botanical Garden of the University of Vienna
Belvedere Palace
Directions to Event Location from the NH Danube City

From the Airport

City Airport Train (CAT): Take the CAT until you reach Landstrasse/Wien Mitte, then transfer to the U3 undergound (orange line) in the direction of Ottakring. Get off at Neubaugasse and go out the Stiftgasse exit. 

S-Bahn: Take the S-Bahn (S7) until you reach Landstrasse/Wien Mitte, transfer to U3 (orange line) in the direction of Ottakring. Get off at Neubaugasse and go out the Stiftgasse exit. 

Bus: Take the Vienna Airport line bus to Westbahnhof, transfer to U3 (orange line) in the direction of Simmering.  Get off at Neubaugasse and go out the Stiftgasse exit. 

From the Train Station

From the Westbahnhof train station, take the U3 underground (orange line) in the direction Simmering. Get off at Neubaugasse and take the Stiftgasse exit. 

By Car

From the north: 
Take the Gürtel exit, then drive across Währinger Gürtel to Neubaugürtel. Turn left onto Mariahilfer Straße. After the 8th street, turn left onto Stiftgasse and take the next left onto Lindengasse. Garage access to the hotel is at Lindengasse 9. 

From the south: 
Take the Wien Zentrum (Triester Straße) exit. Near Matzleinsdorfer Platz turn left onto Gürtel, then drive across Margaretengürtel to Mariahilfer Gürtel. Turn right into Mariahilfer Strasse. After the 8th street, turn left onto Stiftgasse and take the next left onto Lindengasse. Garage access to the hotel is at Lindengasse 9. 

From west: 
Follow directions to the city center, cross Hietzinger Kai, Schönbrunner Schloßstraße and Schönbrunner Strasse to the Gürtel junction, then turn right onto Mariahilfer Strasse. Turn left after the 8th onto Stiftgasse and then take next left onto Lindengasse. Garage access to the hotel is at Lindengasse 9. 

From East: 
Follow directions towards Vienna, then take Schüttelstrasse until you see an observatory (Urania) on the left-hand side. Turn left onto Aspernbrückengasse. Continue straight ahead. Then get on the Ringstrasse. Follow the Ringstrasse until after the Graz/Linz exit, then turn left at the cross onto Babenbergerstrasse. Turn left  onto Mariahilfer Strasse. After the 8th street, turn left onto Stiftgasse and then take the next left onto Lindengasse. Garage access to the hotel is at Lindengasse 9.
Sponsorship Opportunities
We at GLC, thrive to provide a 5* platform to those interested in building long term partnerships with industry leaders by bringing together a substantial number of top management profiles to this event. Therefore, we offer a limited number of speaking slots as well as a number of other marketing opportunities. i.e.  Exhibition booths, Workshop leaderships, Panel moderation's, Chairmanship, Coffee breaks, Luncheons, Cocktail or Dinner sponsorships, Promotional material distribution, and one-on-one meetings.  With our “GLC à la carte sponsorship package” you are able to choose the degree of your marketing exposure at the event.
Media Partners

Biosave is the leading savings website for Life Scientists.  Search 1,000’s of products from leading suppliers to locate the best products at the most competitive prices. 

A quarterly journal reporting on the safety of medicines and medical devices and helping the reader to comply with the complex regulations for risk assessment, pharmacovigilance planning and surveillance.
Unlike other information sources, PharmacoVigilance Review is dedicated to helping the reader to understand and keep up with the often jargon-ridden regulations which are being continually introduced by the regulatory agencies. Thus this journal does not simply list new regulations – each item comes with analysis and comment on their effect on you and your company.
Other topics covered include reviews on drug safety, risk management, quality management, pre-clinical and post-marketing studies, new EU and FDA requirements, prescription event monitoring, and highlights of relevant conferences.

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PharmaVOICE magazine, reaching more than 29,000 BPA-qualified life-sciences executives, is the forum that allows business leaders to engage in a candid dialogue on the challenges and trends impacting the industry. PharmaVOICE provides readers with insightful and thought-provoking commentary in a multiple-perspective format through forums, topics, and articles covering a range of issues from molecule through market. PharmaVOICE subscribers are also kept abreast of the latest trends and information through additional media resources, including WebLinx Interactive WebSeminars, Podcasts, Videocasts, White Papers, E-Surveys and e-Alerts. Additionally, provides a comprehensive directory of products, services, and solutions for the life-sciences industry. facilitates researchers to find the appropriate antibodies for their respective research project. As an independent and multi-vendor marketplace for research antibodies and thanks to the cooperation with more than 120 different manufacturers, we offer a large selection of Antibodies (over 500,000), ELISA Kits (over 200,000), Secondary Antibodies (13,000), Proteins (150,000), Peptides and Isotype Controls. In addition the scientists receive news and detailed information about the individual antibodies from databases such as the PubMed and others.

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“I would also like to thank you (and your colleague) for the good organization of the conference, I will definitely recommend GLC to other colleagues.”
Head of Division; National Bank of Belgium

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Chief Operating Officer; ING Bank Eurasia ZAO

“Big thank you for excellent opportunity to catch up with the latest Back Office & Operations trends & good networking.”
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Banking Association for Central and Eastern Europe (BACEE)

“Thank you very much for your hospitality and excellent organization. Truly, it was the best event that I joined this year!”
Vice President, Head of Mobile Banking, IT & Social Media - Akbank - Turkey

“It was a real pleasure, as per last year, and I thought you did a great job!”
Vice President Operational Risk, UK, Europe and Middle East Retail and Business Banking – Barclays - UK

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