Legal / Transparency Risk Assessment learning opportunities at EuroMeeting2013

Theme 03 - Legal/Transparency-Risk Assessment (22)

• Title: REGULATORY DATA PROTECTION
  Event Type: SESSION
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Tuesday, Mar, 05
  Time: 9:00AM - 10:30AM
• Title: INCENTIVES FOR PAEDIATRIC CLINICAL RESEARCH
  Event Type: SESSION
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Tuesday, Mar, 05
  Time: 11:00AM - 12:30PM
• Title: LEGAL COMPLIANCE FOR REGULATORY FUNCTIONS - LEARNINGS FROM RECENT ENFORCEMENT ACTIVITIES
  Event Type: SESSION
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Tuesday, Mar, 05
  Time: 2:00PM - 3:30PM
• Title: BIOSIMILARS
  Event Type: SESSION
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Tuesday, Mar, 05
  Time: 4:00PM - 5:30PM
• Title: CLINICAL TRIALS
  Event Type: SESSION
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Wednesday, Mar, 06
  Time: 9:00AM - 10:30AM
• Title: TRANSPARENCY ON DOSSIER AND DECISION MAKING – HAS PUBLIC TRUST INCREASED? 
  Event Type: SESSION
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Wednesday, Mar, 06
  Time: 11:00AM - 12:30PM
• Title: LEGAL AND PRACTICAL ASPECTS OF OFF-LABEL USE
  Event Type: SESSION
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Wednesday, Mar, 06
  Time: 2:00PM - 3:30PM
• Title: Tutorial 02: Analysis of Safety Data from Clinical Trials
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 03: Update on Practical Work with Variation Regulation
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 04: Introduction to Medical Device Regulation
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 05: Recent and Current developments in Pharmaceutical Law
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 7: THE DIALOGUE AND NEGOTIATION PROCESS BETWEEN APPLYING COMPANY AND THE PAEDIATRIC COMMITTEE OF THE EUROPEAN MEDICINES AGENCY 
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 08: Health Technology Assessment of Drugs and Medical Devices
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 09: The European QP for Pharmacovigilance: Everything you ever Wanted to know but were afraid to ask
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 10: Non-Clinical Safety Assessment in Global Pharmaceutical Development 
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 11: Interactions between Regulatory and Intellectual Property, Privacy and Product Liability
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 12: Development Safety Update Report (DSUR) Kick-off in 2011: Then and Know
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 13: Technology Transfer for Biopharmaceuticals Workshop
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 14: Pharmacovigilance Audits and Inspections
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 15: Coding with Confidence
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 16: Understanding Translational Medicine: Benefits and Innovative Approaches 
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM
• Title: Tutorial 17: Creating Compliant Clinical Study Reports for the EU and US
  Event Type: TUTORIAL
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment

  Day: Monday, Mar, 04
  Time: 9:00AM - 12:30PM

Primary care doc: It’s “crazy” that doctors don’t consider costs in patient treatment plans

from MedCity News by Arundhati Parmar

It’s not just patients who are seeking price transparency.

For years, Leslie Ramirez, 46, a primary care, internal medicine doctor in Chicago, , has been frustrated by patients who do not adhere to her care program because they can’t afford to buy a particular medication or undergo a certain test.

“It was so disheartening to hear that the plans that I had made for them weren’t being followed because they couldn’t afford the things that I was telling them to do,” Ramirez, who sees a fair number of uninsured and ...

Primary care doc: It’s “crazy” that doctors don’t consider costs in patient treatment plans

Europe Adopts Transparency Guideline

Mar 28, 2012 By: Stephanie Sutton

The European Medicines Agency (EMA) has released guidance that outlines a European-wide approach for dealing with transparency and access to information included in marketing authorization applications. The guideline identifies which parts of an application dossier can or cannot be released in response to document requests.

According to the EMA, the guidance is a "major step for transparency" when dealing with requests for access to marketing authorization applications and is the first time that a harmonized, European approach to the issue has been adopted. Going forward, all regulatory authorities in the European Economic Area will apply the same principles.

 

For the complete article, please visit PharmTech.com:

http://www.pharmtech.com/pharmtech/News/Europe-Adopts-Transparency-Guideline/ArticleStandard/Article/detail/766339?contextCategoryId=35097&ref=25