New York Professional Events List


Risk Management Plan Summit


Date
Oct 11, 2017 - 08:00 AM - Oct 12, 05:00 PM
Organizer
exlevents
Location
TBD London, UK,

TBD,
London,
US,
ZIP: United Kingdom
Phone: +1 929 900 1853

Risk Management Plan Summit

Risk Management Plan Summit

In the past, complying with the expectations of risk management plans (RMPs) has been challenging on multiple levels. The overhauls to European Medicines Agency Module V and Module XVI this year will bring a tidal wave of complications to the work of professionals charged with developing, implementing and executing RMPs. Notably, the introduction of evidence-based standards for RMPs will upend your practice. You should prepare to target pharmacovigilance to specific drug groups and different segments of the population. Changes to Module V also include mandatory post-approval efficacy and follow-up surveys on the impact of communications and the incorporation of patient preferences into benefit-risk profiles.

With the introduction of RMP mandates across the globe with disparate timelines and requirements, the Risk Management Plan Summit is critical to the development and successful planning and execution of RMPs. Harmonisation is particularly essential to your success, your company’s success and the health outcomes of patients.

This two-day educational conference will showcase best practices and lessons learned in order to ensure delegates are informed, equipped and ready to replicate, implement, and execute and refine RMPs that comply with global mandates. By attending, you will learn from and interact with the foremost experts, risk management leaders, peers and the preeminent thinkers who comprise our esteemed speaking faculty.

Top Reasons to Attend

  1. Get updates on regulations globally including EMA’s GVP Modules V and XVI
  2. Incorporate an app/technological tool as a medium to monitor and track activities at the local level
  3. Implement and harmonise on a global scale from a regional or centralised model with cross-functional teams
  4. Tailor communications to the needs of specific patients with disparate backgrounds
  5. Evaluate drug safety and patient outcomes and incorporate analysis into modifications

Who Should Attend

This conference is designed for professional from pharmaceutical and biotechnology companies with responsibilities in the following areas:

  • Benefit/Risk Management
  • Epidemiology/Pharmacoepidemiology
  • Global/Regional Pharmacovigilance
  • Biostatistics
  • Medical Writing
  • Risk Analysis/Assessment
  • Global Drug/Product Safety
  • Local/Regional Medical Safety
  • Safety Evaluation/Reporting
  • Medical Information
  • Patient Safety
  • Therapy Area Safety
  • Integrated Medical Safety
  • Safety Surveillance/Operations
  • Clinical Data Management
  • Clinical Risk Management
  • Regulatory Affairs/Legal
  • Compliance Management
  • Patient Engagement
  • Pre/Post Marketing
  • Life Cycle Management
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Please contact the event manager Marilyn below for the following:
 
- For Tickets/Registrations,
- Discounts for registering  5 or more participants.
- If you company requires a price quotation.
 
Event Manager Contact:


marilyn.b.turner(at)nyeventslist.com or Contact:  +1 929 900 1853
 
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
 
NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS
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This Event Listing is Promoted by  New York Media Technologies LLC in association
with EXL Events Inc.

 
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Agenda


The agenda for the Risk Management Plan Summit is under development.

If you are interested in speaking at this event or would simply like to learn more, contact Brian Anderson, Conference Production Director, at [email protected] or +1 212-400-6232.

The following titles are excerpted from the preliminary agenda

Global Overview

  • Achieve RMP Global Harmonisation Through a Strategic Core Strategy
  • Discuss Developments, Trends and Pending Changes
  • Study RMP’s Parallels to REM’s and Adaptable Practices

Regulatory/Compliance

  • Hear Updates and Clarifications to Module V and Discuss Timelines and Pitfalls for Module XVI
  • Determine the Need and Steps for Submitting Modifications and Revisions
  • Describe the Content of PBRER and Practical Considerations for Planning
  • Resolving Contradictions Between RMP and PSUR
  • Compare and Contrast Risk Management Plan Regulations Around the Globe

Assessment/Efficacy

  • Conduct Thorough Post-Authorization Efficacy Studies by Incorporating Proven Methods and Metrics of Assessments
  • Develop Assessments that Minimise Miscommunication/Misunderstanding Resulting Cultural Differences and Language Barriers
  • Design Low-Impact, High-Yield Relevant Surveys

Technology

  • Keep Pace with Technological Advances (e.g., mobile apps, electronic reporting, social media) and Regulations Related to Safety Reporting
  • Examine Outsourcing Options and Strategies to Resolve Resource Challenge
  • Align and Utilise Signal Management Through Sound Data Mining Solutions and Methods

Event Categories
BUSINESS & MANAGEMENT CONFERENCES
,
HEALTH AND MEDICINE CONFERENCES
,
Healthcare
,
Technology
Keywords: fun, analysis, assessment , Clinical , communication , conference , design , developing, development , Educationa




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