£1,440 – £4,340

Risk Management Plan Summit (EXL)

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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



Agenda

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

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 Partners


MEDtube

MEDtube is an innovative video education platform for health professionals. It allows sharing videos and other materials with a community of more than 110,000 users worldwide, as well as building e-learning courses. The videoteque is updated daily and now contains almost 15,000 videos.


PharmaLeaders

PharmaLeaders.com is an online environment dedicated to enriching the careers of more than 200,000 life sciences professionals. With breaking news and informative content grouped into one of nine segmented channels, in-depth special reports, job and events postings, and so much more, industry executives, manufacturers, marketers and educators can count on PharmaLeaders for the tools they need to succeed in today’s competitive market environment.

pharmaphorum.com

pharmaphorum drives innovation within the pharmaceutical industry, by bringing together healthcare through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.


PharmaVOICE

PharmaVOICE magazine, reaches more than 41,000 qualified subscribers and 100,000 users with its digital edition. PharmaVOICE is the forum that allows business leaders to engage in a candid dialogue on the challenges and trends impacting the industry. PharmaVOICE provides readers with insightful and thought-provoking commentary in a multiple-perspective format through forums, topics, and articles covering a range of issues from molecule through market. PharmaVOICE subscribers are also kept abreast of the latest trends and information through additional media resources, including Social Media, WebLinx Interactive WebSeminars, Podcasts, Videocasts, White Papers, E-Surveys and e-Alerts.


PM360

PM360 is the premier, must-read magazine for marketing decision makers in the pharmaceutical, biotech, and medical device industries. Published monthly, PM360 is the only journal that focuses on delivering the full spectrum of practical information necessary for product managers and pharma marketing professionals to succeed in the complex and highly regulated healthcare environment. The journal’s targeted and insightful editorial focuses on issues that directly impact critical decision making, including: planning and implementation of cutting edge strategies, trends, the latest technological advances, branding/marketing, advertising/promotion, patient/professional education, sales, market research, PR, and leadership. Additionally, the ‘360’ in our title signifies the combination of this critical, how-to info with personal and career insights for an enjoyable and thought-provoking read. By providing the full circle of enriching content, PM360 is truly an indispensable tool for busy and productive marketing professionals to stay at the top of their game.


Technology Networks

Technology Networks is an internationally recognised publisher that provides access to the latest scientific news, products, research, videos and posters. Our global community is made up of over 300,000 researchers and scientific professionals from the life science, drug discover and analytical arenas.


International Compliance Association

International Compliance Association is a professional organisation dedicated to the pursuit of excellence in compliance, anti-money laundering and financial crime prevention. ICA offers internationally recognised professional qualifications that help improve knowledge, enhance skills and minimise risk for firms. For novice and experienced practitioners alike, ICA certificate and diploma programmes are a benchmark of competence and excellence. Being a member of ICA, a global community, demonstrates a commitment to the highest standards of practice and conduct, enhances your professional reputation and employability and significantly, protects and improves the performance of your organisation.

Pharma Advancement

www.pharmaadvancement.com is a leading information centric website.

On one side www.pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insight into the happenings in the Pharma sector.

And on the other side runs with an objective to promote its client and advertisers through various online marketing activities which are circulated to the key decision makers within the industry.

www.pharmaadvancement.com provides a repository of information in the form of Knowledge Bank, which brings all the latest News, Press Releases, Research Works, Articles from industry experts, Industry Reports, White Papers, Webinars etc. Our Knowledge expert team provides archives developed through scientific approach which includes in-depth interviews with client, articles from industry experts, exhaustive research, data reviews and publishing the knowledge to make sure that our clients do not miss important information.



Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
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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