$1,885

2nd Real-World Evidence Forum (exl) AS

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Philadelphia

Philadelphia, PA

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2nd Real-World Evidence Forum

Real-world evidence can provide key insights that will help drive down medical costs, as well as improve both product safety and effectiveness. Unfortunately, the relevance and validity of user collected and practiced based real-world data is a challenge within the clinical health industry. If real-world data isn’t properly analyzed it can be tricky to utilize successfully. Companies must have an in-depth understanding of the data landscape and how to assess real-world data sources, analytics and applications to build real-world data platforms.

Proving safety and effectiveness through a randomized clinical trial no longer secure success and profitability of a drug or device. Companies must now demonstrate evidence of successful real-world outcomes to distinguish their products in an aggressive environment. While also fulfilling requests of regulators, insurance companies, healthcare providers, and patients.

The Real-World Evidence Forum, taking place on July 10-11, 2017 in Philadelphia, will bring together clinical health professionals to address how to operationalize the process of collecting real-world data. Our expert staff will discuss how to utilize real-world evidence to demonstrate both clinical effectiveness and cost-effectiveness of your product. Attendees will gain a better understanding of how electronic data sources are changing the way real world data is being collected. This conference will offer attendees insight on how real-world evidence will help decrease costs and development timelines, define innovative outcomes, and minimize the number of patients exposed to less useful medications.



Advisory Board

John A. Bardi, Vice President – Government Affairs Advocacy and Digital Medicines Business Development, OTSUKAJane Fang, Research and Development Information Head for Clinical Biologics, ASTRAZENECA/MEDIMMUNEElizabeth MacLean, PharmD., Ph.D., Director Global Health and Values/US Outcomes and Evidence – Oncology, PFIZER INC.



Top Five Reasons to Attend

  1. Discuss how the industry is transforming the drug development process through the use of real-world evidence
  2. Learn to operationalize the process of collecting real-world data
  3. Utilize real-world evidence to demonstrate both clinical effectiveness and cost-effectiveness of your product
  4. Discover how electronic data sources are changing the way real-world data is being composed
  5. Examine the need for greater data sharing practices and transparency of methods when used for regulatory decision-making



Who Should Attend

This conference is designed for professionals from pharmaceutical companies with responsibilities in the following areas:

  • Real-World Evidence
  • Phase IV
  • Post Market Surveillance
  • Late Phase
  • Medical Affairs
  • Data Management
  • Project Management
  • Business Development
  • Clinical Development
  • Global Medical Affairs
  • Observational Research
  • HEOR / GHEOR
  • Patient Safety Surveillance
  • Clinical Trial Design and Management
  • Data Management Operational Support
  • Regulatory Affairs
  • Registry
  • Drug Safety
  • Patient-Reported Outcomes
  • Post-Approval

This event is also of interest to:

  • CROs
  • Clinical Trial Management Software Providers
  • Big Data Platforms


Topics under consideration:

Data Collection

  • Refining the outcomes by feeding patient information back to development groups to evaluate endpoints
  • Address the lack of standard universal data and how it presents a challenge in the effective analysis of Real World Data
  • Optimize bottlenecks to reduce the time between receiving data and preparing it for final research and analysis
  • Linking datasets (pharmacy claims, electronic medical records, laboratory data, social media and work habit demographics)
  • Building a platform
  • Using small-data sets instead of building out big data
  • Collection of better data

Safety

  • Safety vs. Marketing (public health and industry health)
  • Use RWD to identify a drugs usefulness and adverse events
  • Developing models to predict probability of events so that corrective measures can be taken

Regulations

  • Opportunities and challenges for generating industry-wide standardizations
  • Understanding regulatory framework in the US and worldwide
  • Having an awareness of regulatory and compliance safeguards to minimize risk
  • Identify regulatory contact points for help with trial approval
  • Identify submission elements for trial approval
  • Aggregate and submit the necessary pre-market data
  • Comply with necessary ongoing reporting, auditing, and monitoring requirements
  • EU vs. US regulation

Trial Design and Protocol

  • Determine the right type of post-market study
  • Application of late-stage protocol
  • Early planning of a drug’s approval
  • Site and patient retention
  • Bridging the gap between clinical data and commercial data

mHealth

  • Using technology for data collection
  • The growing use of EHRs
  • Virtual trials
  • Mobile tools supporting the development portfolio
  • Develop easier ways for patients to get information to their doctors

Establishing the right partnerships

  • Balancing scientific and commercial values of non-interventional studies
  • Utilize pharmacists and doctors for data collection
  • Supporting clinical trial success with RWE investments
  • Harnesses RWD before approving new and expensive treatments

Patient Centric Approaches

  • Understand the new types of options and strategies such as social media and electronic medical records
  • Identify challenges of patient recruitment and retention for observational studies
  • The advantages of patient recruitment using a centralized investigator, direct-to-patient (though the pharmacist) model
  • New ways to engage with and pre-screen patients through their pharmacist



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 ALLOWED ON REGISTRATIONS
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Philadelphia, PA

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