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Tuesday, February 5
 

13:30 CET

#CHS02: Beyond Translation in the Centralised Procedure: Reducing the administrative burden of the linguistic review process
Component Type: Session



Chair

Ben Rainforth

Tuesday February 5, 2019 13:30 - 14:00 CET
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Content Hub, Session
 
Wednesday, February 6
 

10:15 CET

#PS04: Oral Poster Session 4 - Regulatory Science & Value and Access Content Hub
Component Type: Session



Speaker

An overview of the current status and trends in the Breakthrough Designation, PRIME and SAKIGAKE expedited review programs
Pedro Borga, MPharm

Early Actions granted by FDA: a review of the frequency and importance of NDA/BLA approvals in advance of DUFA action date
Camille Metais, MSc


Speakers
CM

Camille Metais

Senior Director Regulatory Affairs, Alexion Pharma GmbH
avatar for Pedro Borga

Pedro Borga

Consultant, Lifescience Dynamics Ltd

Wednesday February 6, 2019 10:15 - 10:45 CET
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Poster Session, Session

11:15 CET

#CH402: Policy 0070 Submissions – Comparison of Anonymisation Methodologies – Advantages and Disadvantages
Component Type: Session
Level: Intermediate



Learning Objectives

Comparison of anonymisation techniques and assessments; advantages and disadvantages; EMA Policy 0070 Phase I.

Chair

Ingeborg Cil, MSc

Speakers
avatar for Ingeborg Cil

Ingeborg Cil

Lead, Clinical Trial Data Anonymization, Shire Now Part of Takeda
Ingeborg Cil is Associate Director, Clinical Trial Transparency, at Shire Now Part of Takeda. She received her Master of Science in Computer Science from the Technical University Vienna. After working several years as software developer, project manager, supervisor, Ingeborg moved... Read More →

Wednesday February 6, 2019 11:15 - 11:45 CET
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Content Hub, Session

12:00 CET

#CH403: Bridging the Gap between Managed Healthcare and Clinical Research
Component Type: Session
Level: Intermediate



Learning Objectives

Strategies for integrating Managed Healthcare organizations into Clinical Research. Challenges to work with Medicare dependent entities. Benefits of incorporating Managed Healthcare organizations in research projects.

Chair

Ves Gitchev, MD

Wednesday February 6, 2019 12:00 - 12:30 CET
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Content Hub, Session

12:30 CET

#CH406: Unmet Medical Need Papers
Component Type: Session



Chair

Rick Vreman

Wednesday February 6, 2019 12:30 - 13:00 CET
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Content Hub, Session

15:15 CET

#CH404: EMA Policy 0070 - Arguing for a Pro-Active Anonymisation Process and External Validation of Identification Risk and Utility
Component Type: Session
Level: Intermediate



Chair

Friedrich Maritsch, PhD

Speakers
avatar for Friedrich Maritsch

Friedrich Maritsch

Data Anonymization Lead, Shire Now Part of Takeda
Friedrich Maritsch, Sr. Director, Data Anonymization Lead at Shire’s (now part of Takeda’s) Clinical Trial Transparency Group, holds a PhD from the University of Vienna in Austria and has over 25 years of experience in the pharmaceutical industry, working in various capacities... Read More →

Wednesday February 6, 2019 15:15 - 15:45 CET
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Content Hub, Session

15:45 CET

#CH405: Aligning expectations for product label terminology: disease modification in neurodegenerative disorders as a case example
Component Type: Session
Level: Intermediate



Chair

Anne Vinther Morant, PhD, MSc

Speakers
avatar for Anne Morant

Anne Morant

Senior Specialist, Regulatory Science & Advocacy, H. Lundbeck A/S
Anne Vinther Morant is a Senior Specialist in Regulatory Science & Advocacy at H. Lundbeck A/S. Since 2008 she has worked in various functions within regulatory strategy and regulatory science with focus on development of medicines to treat psychiatric and neurologic diseases. Anne... Read More →

Wednesday February 6, 2019 15:45 - 16:15 CET
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Content Hub, Session
 
Thursday, February 7
 

09:45 CET

#CH407: Coping with a Medicine Mid-Life(Cycle) Crisis: Future Opportunities and Challenges in the Management of Post-Licensing Change
Component Type: Session



Chair

Simon Bennett, MSc

Speakers
SB

Simon Bennett

Director, EU Regulatory Policy, Biogen
As Director of EU Regulatory Policy at Biogen, Simon is responsible for developing and leading Biogen’s European regulatory policy agenda and associated activities. Simon started at Biogen in 2003 in the clinical group before moving into Regulatory Sciences and undertaking increasingly... Read More →

Thursday February 7, 2019 09:45 - 10:15 CET
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Content Hub, 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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