th
6 Annual
Conference
safety patients
regulatory expectations compliance
Pharmacovigilance and Risk Management Strategies www.fleming.events
27 – 29 January 2016 | Munich, Germany
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Conference In Numbers 10
3
19
Hours of Networking
Days
Participating Countries
19
21
91
Speakers
Hour Program
Attendees
Top Speakers Shelley Gandhi
Waltraud Trabe
Michael Ibara
Pharmacovigilance Director NDA Group
Head of Department Blood, Tissue & Vigilance Austrian Agency for Health and Food Safety (AGES)
Kristina Strutt
Sabine Poltermann
Sara Gama
Karen Pattenden
Karsten Lollike
Francoise Sillan
Jens-Ulrich Stegmann
Doris Irene Stenver
Nour Zibian
Tanja Peters
Andrew Moore
Dr. Simon Ingate
SVP Global Pharmacovigilance, EU QPPV Ipsen
Sr Director Drug Safety and Public Health Gilead Sciences
VP, Head Clinical Safety and Pharmacovigilance GSK
Global head of PV Intelligence, Deputy EU QPPV Boehringer Ingelheim
Head of Drug Safety Project Excellence Novartis
Head of Digital Healthcare CDISC
Group Head – Safety Processes and Aggregate Reporting Novartis QPPV, Head of QPPV office and Pharmacovigilance Policy Sanofi
Corporate VP, QPPV Novo Nordisk
Chief Medical Officer, Member of the PRAC Danish Health and Medicine Authority
Senior Director Global Drug Safety, Head of QPPV and Alliance Office Grunenthal
Sr. Safety Scientist UBC
Principal Consultant - Safety Gauge Product Manager Pope Woodhead & Associates Ltd
Top Presentations Signal Detection
Patient Safety is everybody’s business
PSMF: Lessons Learned, Regulator’s perspective
Safety Exchange Agreements: Requirements
Pharmacovigilance in Africa a continent with specific challenges to ensure patient safety
Pharmacovigilance Intelligence as a Global Function
by NDA Group
by AGES
by Ipsen
by Gilead Sciences
by Boehringer Ingelheim
by GSK
www.fleming.events
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Highlights Workshop on Social Media in Pharmacovigilance
The most current regulatory updates from PRAC
Workshop on PSMF
Benefits of the global harmonization of PV activities
Workshop on Signal Detection and Quality Assurance of PV Data Collected Most common findings and Red Flags in inspections
Our Thank You We would like to thank: • our partners and sponsors for supporting us and the whole event, • our speakers and advisors for contributing with their knowledge, experience and strategies, and • our delegates, who were a great audience that enthusiastically proposed their ideas and boosted discussions. We were very delighted that you chose to attend the 6thAnnual Pharmacovigilance and Risk Management Strategies Forum in Munich, Germany and we had the chance to meet you. We believe that the event was beneficial for you in terms of both learning and networking. I hope to see many of you at the Pharmacovigilance and Risk Management Strategies Forum again and look forward to hearing your new findings and experience.
Lesly Solei
Conference Producer
safety patients
www.fleming.events
regulatory expectations compliance
Post Show Report
Participating Companies 4C Pharma Solutions Abbot Laboratories AGES Amgros I/S Aspen Pharma AstraZeneca Axon Neuroscience Barrington James Basilea Pharmaceutica Bayer Pharma Bioclinica Biogen Bionika Pharmaceuticals Biotest Boehringer Ingelheim Boehringer Ingelheim Israel Bracco Imaging C3i Healthcare Connections CDISC Celgene R&D ColgatePalmolive
Danish Health and Medicines Agency Drug Safety Research Unit Fishawack Archimed Genesis Pharma Gilead Sciences Gilead Sciences International Grunenthal GSK Horizon Pharma INC Research Ipsen Johnson and Johnson MorphoSys MundiPharma Research NDA Group Novartis Novartis Pharma Novartis Poland Novo Nordisk Novo Nordisk A/S Olainfarm
Orphan Europe Pfizer Pharmasol Pierre Fabre Medicament Pope Woodhead & Associates Product Life Product Life Group Przedsiebiorstwo Farmaceutyczne LEK- AM Sandoz International Sanofi Sanofi Pasteur Springer UBC UCB Biopharma UCB Pharma United Therapeutics Université de Bordeaux Virbac Walmark
Our Partners Gold Sponsors:
Silver Sponsors:
Bronze Sponsors:
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th
7 Annual
The Next Annual Pharmacovigilance & Risk Management Strategies 25 - 27 of January 2017, Amsterdam, Netherlands For sponsorship opportunities:
For media partnership opportunities:
Jenai Simmons Senior Business Development Manager
Martina Hrabinska Marketing Manager
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