GLC Europe

3rd Annual Pharmacovigilance Forum

3rd Annual Pharmacovigilance Forum

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

The 2nd Annual Pharmacovigilance Forum continues to investigate the impact of the evolving regulation both on the national and international level. It reveals such strategies and best practices that can be adopted in order to overcome such problems as risk mitigation, data collection and management, monitoring adverse drug reactions and challenges in the field of QPPV. Furthermore, the event provides updates on the assessment of PRAC, PSUR principles and the newly launched Black Triangle Symbol legislation.The Conference will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry.

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 

Media Partners

Pharma Focus Asia is a bi-annual magazine from Ochre Media Pvt. Ltd. Pharma Focus Asia covers important issues and trends shaping the future of the Pharma industry across Asia and rest of the world. It is the leading Pharma title in print as well as digital versions serving the information needs of key executives from the world’s leading pharmaceutical companies.

Pharmaceutical-tech is a connecting point for buyers and suppliers in the pharmaceutical sector. With its unique content proposition, Pharmaceutical-tech serves as the platform of choice for professionals seeking to create fruitful partnerships and stay abreast of the day-to-day developments in the Pharmaceutical sector.

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.

We help scientists to find the right products in our database. Similar products can be compared, our technical hotline offers consulting and the possibility to order directly with us.
We help suppliers to reach the right audience. Product listings on antibodies-online increase the visibility of your products on the internet. A complement to existing distribution channels and a way to professionalize internet sales channel at zero risk. Joining our platform does not incur any fixed costs.

Pharmalicensing is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique Partnering Search service and its global network of industry experts to enable companies to identify and engage with appropriate partners around the world.

Pharmalicensing, and its sister service Medical Device Licensing ( are actively utilized by over 200,000 industry professionals each month. Pharmalicensing is a division of IP Technology Exchange, Inc.

Medical News Today is the largest independent medical and health news site on the web - with over 7,000,000 monthly unique users it is ranked number one for medical news on Google and Yahoo!. Medical News Today is used by Blue Chip pharmaceutical and health organizations, advertising agencies, PR companies and vertical ad networks to deliver targeted disease/condition and general health campaigns. For more information contact or visit

Pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.  

Packaging journal is one of the leading professional journals of the packaging industry. As an integrative information medium for decision-makers, it reports independently and in a compact form.  Due to its mainly user-specific coverage it represents an ideal guide in a permanently expanding market sector. It is the only packaging magazine in Germany with English abstracts. Read our free E-Paper version online on

A pioneer in the field, HealthEconomics.Com is the world’s most comprehensive and credible website for resources and jobs in healthcare value and market access.  A trusted resource, HealthEconomics.Com contains the hottest news, jobs, policy updates, professional development, and education resources, and offers unparalleled advertising opportunities.As the #1 Google ranked website in health economics, HealthEconomics.Com attracts 11,000 visitors every month and the well-respected Newsletter reaches 20,000 professionals every week. The comprehensive content is carefully selected by a discerning health economist editor, making us the most visited website for healthcare value and market access in the industry, with visitors encompassing all corners of the globe.

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.

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Our Partners


"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." 

"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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