Skip to main content

IDMP: Data Collection

Compliance Key INC - Regulatory Compliance Training


                                              Joel Finkle
Joel Finkle is Director, Regulatory Innovation and IDMP Strategy for ACUTA. In this role he brings new technologies and regulatory data standards to ACUTA's bio/pharmaceutical customers to ensure compliance and process improvements.
 Webinar Id:  LSHCJI001
 12.30 PM PT | 03.30 PM ET 
 01/23/2018
 Duration: 60 mins 
Overview
This session will review the basic requirements of the initial planned European implementation of the ISO IDMP standard, then explore how the data for a product could be gathered for entry into a RIM system or what is expected in the agency web portal. Benefits of integration in a RIM environment, and downstream use of the data, will be covered.
Why should you attend this webinar?
Compliance with IDMP is not expected for a couple years, but the amount of preparation for existing products is extensive. Getting ahead of the deadlines will make compliance possible, while adding value by codifying the data found in company documentation. The downstream use of IDMP data for regulatory intelligence, marketing and supply chain will also add value to your company.
Areas Covered in the Session:
  • ISO IDMP Standard Overview
  • European Medicines Agency (EMA) Implementation Plans and Progress
  • Mapping data from XEVMPD to IDMP
  • Gathering details from the Summary of Product Characteristics (SMPC)
  • Completing the European Requirements from submissions and other documentation
Who can Benefit:
Regulatory Operations Staff and Management
Regulatory Affairs Staff and Management
Visit:https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=848&speakerid=195

Compliance Key INC
717-208-8666
Labels:
Location: United States

Comments

Post a Comment

Popular posts from this blog

HIPAA Compliance with the New Omnibus Rule: How to Pass an Audit to Avoid Penalties and Criminal Convictions

Compliance Key INC  -  H ipaa webinar                                           Jonathan P. Tomes Jonathan P. Tomes , J.D., is Keynote Speaker at Compliance key Inc. He is a health care attorney practicing in the greater Kansas City.   Webinar Id:   HIPHJPT001  2:30 PM PT | 03:30 PM ET    01/18/2018  Duration: 60 mins  Overview Before the HITECH Act, DHHS could audit covered entities for HIPAA compliance, but did not have to. With that Act, now the must audit those entities and business associates as well. In the first audits, the Phase I audits, DHHS came on site. The subsequent Phase II audits, however, were paper audits in which those audited had to provide documentation of their compliance. As yet, we do not know what form Phase III will take, but the necessary actions to prepar...
Post a Comment
Read more

HIPAA Compliant Fundraising Under New Rules - 2019

Compliance Key  -  H ipaa   Compliance Training HIPAA Compliant Fundraising Under New Rules - 2019 Joel Simon Joel Simon is one of the nation's leading experts on the fund raising aspects of HIPAA. Joel has been a member of the Maryland bar for 30 years, and his professional experience includes work as the assistant general counsel of a community hospital. Joel is an editor of "Fundraising Under HIPAA" published by the Association of Fundraising Professionals. He has lectured on Fund Raising under HIPAA to national audiences since the original HIPAA regulations were first proposed 17 years ago. Read More Overview Not-for-Profit organizations that are governed by HIPAA often need or want to fund raise from their patients, clients, or families. What protocols should be in place to maximize philanthropic opportunities under HIPAA? What compliance measures need to be in place and assessed to properly use protected health information for fund raisi...
Post a Comment
Read more

New 2019 HIPAA Guidance on De-Identifying Protected Health Information

Compliance Key  -   HIPAA Compliance Training Overview This seminar will be addressing how practice/business managers or compliance officers need to get their HIPAA house in order, as HIPAA is now fully enforced and the government is not using kid gloves anymore. It will also address major 2019 changes taking place with the Health and Human Services regarding the enforcement of the HIPAA law as well as detailed discussions on the Phase 2 audit process and current events regarding HIPAA cases (both in courtrooms and from real-life Audits). Our instructor - Mr. Brian Tuttle  has over 20 years of experience in working as Compliance auditor and has been an expert witness on multiple HIPAA cases. He`ll thoroughly explain on HOW and in WHAT scenarios patients can claim for cash remedies. More importantly, Brian will show you how to limit those risks by simply taking proactive steps and utilizing best practices. Why should you attend this seminar? This Sem...
Post a Comment
Read more