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
Denmark
 
 
Susana Goncalves
Sr. Pharmacovigilance Leader
Novartis
Switzerland
 
 
Karsten Lollike
Corporate Vice president
Novo Nordisk A/S
Denmark

  
Vincent Jullien
Global Head of Pharmacovigilance, EU QPPV
Guerbet
France

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

  
Giovanni Furlan
EU QPPV
Helsinn Birex
Ireland


 
Anca Miclea
Senior Specialist Medical Safety & Epidemiology
Abbott Laboratories
Germany

  
Raquel Rogers
Safety Risk Lead
Pfizer
United Kingdom

 
Heinz Weidenthaler
Director Pharmacovigilance, QPPV Bavarian
Nordic
Germany

  
Professor Saad Shakir
Director 
Drug Safety Research Unit
United Kingdom

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


  
Nele Matthijs
Pharmacovigilance inspector
FAGG 
Belgium    
   


 
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)
Belgium

  
Anne Gramkow
Head of Safety and QPPV
Pharmacosmos
Denmark

Prestigious Advisors

Karsten Lollike
Corporate Vice President
Novo Nordisk A/S
Denmark



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



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



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



Zsuzsanna Müller
Pharmacovigilance Manager
CSC Pharmaceuticals Handels GmbH
Austria





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.
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Testimonials

"Thanks for your great work in getting this conference together and for the invitation."
VP HR Global & Europe - DHL Express - Germany

 

"I wish to thank you for inviting me to your Conference which was very interesting and excellently organized."

MSc Programme in Human Resource Management - Athens University of Economics and Business – Greece

 

"Thank you very much for the excellent experience"

HR Specialist - Millenium BCP – Portugal

 

"Thank you for what was overall a very good conference: interesting, right speakers, right audience, very good facilitation and proper organization."

HR Director – LibanPost – Lebanon

 

"The best HR Conference I have ever attended. Congrats and keep up the good job."

Head of HR - Banca Comerciala Carpatica – Romania

 

"Thanks for a good conference. Many interesting presentations!"

Managing Director – PharmaEvidence

 

"It was very good to meet you in Frankfurt, and congratulations on organizing such a successful event."

Clinical Director - All Wales Therapeutics and Toxicology Centre - United Kingdom

 

"It was an excellent one under GLC’s organization; I am honored for being a part of it. I really appreciated of your organization during the Forum from which I benefited a lot, thank you very much for everything indeed, you are wonderful."

Chief Auditor – Central Bank of Turkey –Turkey

 

"Excellent results. I really enjoyed the conference myself. Think it was well organized and good participation from the audience."

Chief Auditor for Functions and Capital Resolution Group - Royal Bank of Scotland, Internal Audit

 

"The organization was fantastic"

Director Internal Audit - Bank of Slovenia – Slovenia

 

"It was a pleasure to attend and speak at the 3rd IA Conference! The environment was outstanding and the presentations were very interesting"

Director of Internal Audit (Head of Group) – Portuguese Mutual Guarantee System (SPGM)

 

"Thanks a lot for arranging such a good Forum. Thank to GLC for their friendly support"

Head of Internal Audit & Compliance - Eco Trade and Development Bank – Turkey


“The event was really good and I must say I got exceptionally lot good and useful information, so well done!”
Head of PPMO & Cross Functions - Erste Group Bank AG

“Thank you very much once again for the organization, the forum was great!“
K&H; Head of Corporate Customer Service

“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

“I found this forum to be extremely interesting & useful, & very valuable from the practical perspective.”
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.”
Head of IT Strategy and Enterprise Architecture-Nordea
“Thank you again for the excellent event, it was a pleasure to attend and speak”
Secretary General
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

"Good number of people. Senior participants are key to have valuable peer-to-peer discussions!" 
Baxter Director of Market Access EMEA

"Well organized!" 
Novartis Global Brand Pricing Director

"Attention to all details during the organisation, kindness and supporting spirit of all the staff." 
Martifer Solar Regional Manager Mediterranean

"Several high profile speakers." 
United Bulgarian Bank Project Finance & Loan Syndication Unit Manager

"Well organized in general, extremely helpful staff." 
Hypo-Alpe-AdriaHead of Group Department Integrative Steering

"Good/Prepared presentators with relevant topics."
Raiffeisen Bank Retail Risk Analyst

"Selection of speakers: 60% of them were excellent." 
Ceska Sporitelna Scoring Model Specialist

"Great venue, excellent food & refreshment, well organized and according to schedule - well done!" 
DnB Nord Risk Manager

"Professional Organizing the event..." 
Raiffeisen Bank Head of Underwriting

"It was comprehensive." 
Danske Bank Credit Controller

"Organisation of the event was very good!" 
Erste Head of ALM

"Location - Room - Catering - Host - Were all excellent" 
RBS Vice President GTS Market Infrastructures

"Very interesting topics and very good speakers, good organisation."
Polbank EFG Market and Liquidity Risk Team Manager Risk Management Department

"Attraction of knowledgeable speakers, valuable content, audience."
Clearstream Chair and Head of Global Securities Financing EMEA

"Good organisation and speakers." 
Belfius Bank Head of Risk Analytics

"Good organisation on the spot; facilities, breaks; interesting panel of speakers." 
ING Bank CFO

"Place, organisation, quality of guests." 
Innotech CRM Project manager

"Low Pressure of Sponsor, very good level of speakers/presentations." 
Almirall Business Unit Director

„The overall organization was fine” 
Internal Audit, Banca d’Italia

„The organization is good and the chairman is professional” 
Quality Assurance Manager, Euroclear SA/NV

„Good overall program” 
Deputy Head of Internal Audit, Norges Bank

„Good time management over the days, friendly staff – helpful as well” 
Business Manager, ING

„Good organisation and lecturers” 
Internal Audit Director, Erste Bank Montenegro

„Good presentations” 
Head of Internal Audit, Banske Bank


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