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 changes 2018 and How to comply?

Compliance Key INC  -  HIPAA W ebinar                                                   Brian L Tuttle Brian Tuttle is Keynote Speaker at Compliance key Inc . He is Certified Professional in Health IT (CPHIT), Certified HIPAA Professional (CHP), Certified Business Resilience Auditor (CBRA) with over 17 years experience in Health IT and Compliance Consulting.     Webinar Id:   HIPHBLT001 10:00 AM PT | 01:00 PM ET  01/23/2018 Duration: 90 mins  Overview This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule, Trump administration, and any other applicable updates for 2018 and beyon...
Post a Comment
Read more

Strategies for Becoming a Business Partner to Your Healthcare Leaders.Compliance Key INC -

Compliance Key INC  -  Healthcare Training Online                                                    Jay Anstine Mr. Anstine's professional background includes working on the provider and the payer side of the market, for large for-profit and non-profit health systems, and small physician-owned entities. In tackling the countless regulatory and operational issues for these diverse organization types, he has developed a deep understanding of the business of healthcare and the regulations that govern the industry.  Webinar Id:  LSHCSJA022  10:00 AM PT | 01:00 PM ET  12/13/2017  Duration 60 mins  Overview All too often compliance is seen as an obstacle or otherwise viewed negatively by healthcare leaders. This presentation will discuss strategies and insights to help the compliance of...
Post a Comment
Read more

Form I-9 Compliance For Small Business

Compliance Key INC  -  Compliance Online Training                                  Matthew W. Burr Matthew Burr has over ten years of experience working in the human resources field, starting his career as an Industrial Relations Intern at Kennedy Valve Manufacturing to most recently founding and managing a human resource consulting company; Burr Consulting, LLC. He specializes in labor and employment law, conflict resolution, performance management, employee relations and work with labor unions.   Webinar Id:  CICMF001  12:30 PM PT | 03:30 PM ET  11/28/2017  Duration 60 mins  Overview This training will focus on the importance of I-9 compliance for small businesses. The training will introduce the I-9 forms, importance of filling out the forms correctly, retention process and proactive I-9 audits. We will also ...
Post a Comment
Read more