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

Compliance Key INC
717-208-8666

Comments

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...

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...

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...