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

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

Classifying Medical Devices in US and EU

Compliance Key INC  -  Healthcare Compliance Webinars Overview The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.The determination process, how you apply the classification process to your device, is complex and requires several levels of analysis to make the proper device classification. Proper medical device classification is the fundamental first step in submitting your device for approval anywhere in the world. This webinar will detail the medical device classification process for the United States through the FDA and will overview the very complex process for medical device classification within the EU. Specifically, this webinar will provid...
Post a Comment
Read more

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