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Tuesday, February 5
 

13:30 CET

#PS02: Oral Poster Session 2 - Clinical Development & Pharmacovigilance Content Hub
Component Type: Session



Speaker

Considerations for outsourcing EU QPPV services taking into account the impact of Brexit
Kosta Cvijovic, PhD, MPharm

Internal Safety Advisory Groups (ISAG): A Win-Win for Effective Decision-Making in Biopharmaceutical Companies
Eric Cohen, DrMed

CAST analysis of UK pregnancies reported after isotretinoin administration
Brian Edwards, DrMed


Speakers
EC

Eric Cohen

Medical Director, Abbvie
KC

Kosta Cvijovic

EU QPPV, Syneos Health
avatar for Brian Edwards

Brian Edwards

Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group, United Kingdom
After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining... Read More →

Tuesday February 5, 2019 13:30 - 14:00 CET
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Poster Session, Session

15:30 CET

#CHS04: Accelerating Clinical Study Start Up with Innovative Technologies
Component Type: Session



Chair

Evi Cohen, MBA, MS

Speakers
avatar for Evi Cohen

Evi Cohen

Global Industry Leader Life Sciences, Appian, United States
Evi is the Life Sciences Industry Leader at Appian. He is an experienced pharmaceutical executive with an extensive background developing global business portfolios with emphasis on new products, technologies, and IP. Previously, as Global Head of Life Sciences at ServiceNow Evi lead... Read More →

Tuesday February 5, 2019 15:30 - 16:00 CET
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Content Hub, Session
 
Wednesday, February 6
 

10:15 CET

#CHS01: New Legislative Requirements in PV: How to Be More Efficient and Minimise Resources
Component Type: Session



Chair

Carmen Arques

Speakers
CA

Carmen Arques

Pharmacovigilance Manager, AZIERTA

Wednesday February 6, 2019 10:15 - 10:45 CET
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Content Hub, Session

14:45 CET

#CHS04: Navigating the Regulatory Landscape for Safety Reporting in Clinical Trials: Key Principles, Best Practices, and Upcoming Automation
Component Type: Session



Chair

Beata Kolon

Speakers
avatar for Beata Kolon

Beata Kolon

Director Medical Safety Services, ICON
Beata Kolon, is Molecular Biologist and PV expert by dedication and passion. In 2007 she joined Roche as Drug Safety Associate in the UK, where she started her career in PV. Later on, she joined ICON Clinical Research in the UK. She got involved in a variety of PV activities in oncology... Read More →

Wednesday February 6, 2019 14:45 - 15:15 CET
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Content Hub, Session

15:15 CET

#CH201: Recent Developments and Possibilities in Using CPRD as a ‘Real World Data Source’
Component Type: Session

For more than 30 years, electronic health records (EHRs) provided by CPRD have supported a range of drug safety and epidemiological studies impacting on health care and producing 2000 publications. Recently CPRD launched a real world clinical research service, designed to increase study efficiencies and reduce costs though EHR-based protocol design, patient recruitment and clinical trials management.

Chair

Janet Valentine, PhD

Speakers
avatar for Janet Valentine

Janet Valentine

Director of Clinical Practice Research Datalink (CPRD), MHRA
Janet Valentine PhD joined the Clinical Practice Research Datalink (CPRD) as Director in 2015. CPRD is the UK Government real world health data research service supporting retrospective and prospective public health and clinical studies. Previously Janet was Head of Population Health... Read More →

Wednesday February 6, 2019 15:15 - 15:45 CET
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Content Hub, Session

15:45 CET

#CH202: Collaborating to Solve the Industry’s Toughest Challenges: Maximizing the Regulator-Sponsor Relationship
Component Type: Session
Level: Basic



Chair

Christine Mayer-Nicolai, PharmD

Speakers
CM

Christine Mayer-Nicolai

Global Head, Global Regulatory and Scientific Policy, EMD Serono
Pharmacist with over 19 years experience in RA, including working for more than 7 years for BPI (German Industry Association), with Merck (now Merck Serono) since 2002/responsible for Regulatory & Scientific Policy Europe

Wednesday February 6, 2019 15:45 - 16:15 CET
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Content Hub, Session

16:15 CET

#PS06: Oral Poster Session 6 - Clinical Development & Pharmacovigilance Content Hub
Component Type: Session



Speaker

Could we do without RCTs? The emergence of single-arm studies as a basis for approval, a meta epidemiologic study
Theo Blaise, MPharm

ClinLine.ru – the first Russian clinical trial platform for Patients, Investigators, Sponsors and CRO
Oksana Karavaeva

Quality Assessment of Published Pharmacogenetic Association in Randomized Clinical Trials, a Systematic Review
Julie Quemeneur, MSc


Speakers
TB

Theo Blaise

Pharmacy resident - Master degree, Universite Claude Bernard Lyon
OK

Oksana Karavaeva

ClinOps Director, IPHARMA LLC
JQ

Julie Quemeneur

Pharmacy and Master 2 Clinical Evaluation Student, Claude Bernard University Lyon 1

Wednesday February 6, 2019 16:15 - 16:45 CET
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Poster Session, Session
 
Thursday, February 7
 

09:15 CET

#CH203: Innovation in Pharmacovigilance
Component Type: Session
Level: Intermediate



Chair

Christian Mueller, DrSc

Speakers
avatar for Christian Mueller

Christian Mueller

Global Head of Safety Analytics and Reporting, F. Hoffmann-La Roche AG
PhD in Immuno-biochemistry at the University of Lausanne in Switzerland (1995). Master program in Applied Statistics (Neuchâtel, 1997) Biometrics in Pharmaceutical Industry: Novartis (1997 – 2017) then Roche (2017 – 2016). Project statistician in Novartis, a 6-month rotation... Read More →

Thursday February 7, 2019 09:15 - 09:45 CET
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Content Hub, Session

09:45 CET

#CH204: Innovative Designs under the New Clinical Trials Regulations
Component Type: Session



Chair

Kirsty Wydenbach, DrMed, MSc

Speakers
avatar for Kirsty Wydenbach

Kirsty Wydenbach

Deputy Unit Manager, Clinical Trials Unit, MHRA
Joined MHRA in 2009, as the Senior Medical Assessor and Deputy Unit Manager in the Clinical Trials Unit. Involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including trials for chemical and biological products, Advanced Therapy... Read More →

Thursday February 7, 2019 09:45 - 10:15 CET
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Content Hub, Session

10:15 CET

#CHS05: Prudenta: An Electronic Solution for Local Literature Monitoring in Pharmacovigilance
Component Type: Session



Chair

Polina Dombure

Thursday February 7, 2019 10:15 - 10:45 CET
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Content Hub, Session

13:30 CET

#PS07: Oral Poster Session 7 - Clinical Development & Pharmacovigilance Content Hub
Component Type: Session



Speaker

Polycyclic aromatic Hydrocarbons in herbal medicinal Products: T Vavvas and G Bode
Gerd Bode, MD, PhD

Meta-analysis of spontaneous remission percentage in placebo arm of biologic agents in randomized controlled trials for lupus
Clémentine POILROUX, MSc

Adaptive trial design with dose-selection and enrichment for assessing 2-OHOA for treatment of glioblastoma
Ursula Maria Garczarek, DVM, AHIP


Speakers
GB

Gerd Bode

University of Goettingen, Honorable Member of the Medical Faculty, Department of Pharmacology Toxicology
Gerd Bode holds board certified specializations in Pathology, Neuropathology, Legal Medicine, Pharmacology and Toxicology. He works now as a lecturer and independent consultant in Toxicology and Pathology. Gerd was long term ICH Topic Leader for Safety Guidelines.
UG

Ursula Garczarek

Associate Director, Strategic Consulting, Cytel
CP

Clémentine POILROUX

6th year pharmacy and Master degree "Clinical evaluation" student, Claude Bernard University Lyon 1

Thursday February 7, 2019 13:30 - 14:00 CET
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Poster Session, Session
 
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  • 01 Stakeholders and Regulatory System Optimisation
  • 02 Evolution of Science and Policy
  • 03 Pharmacovigilance
  • 04 Modern Clinical Research
  • 05 Medical Affairs and Communication
  • 06 Access to Medicines
  • 07 Digital Disruptors
  • 08 Regional Updates
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