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

Risk and Controls Matrix for SOX, Assurance and Internal Audit

Compliance Key INC  -  SOX Training Online Overview This webinar is created to equip young risk and compliance professionals with the skills necessary to prepare a Risk and Controls Matrix, including the following: Discover the objectives, components and requirements of effective internal controls Leveraging internal control frameworks to create a risk and controls matrix Developing risk identification and management strategies to implement now Learning how to design internal controls Learning how to evaluate the design and operating effectiveness of internal controls Why should you attend this webinar? Whether you are planning a SOX engagement, or an internal audit, regulatory compliance requirements, or other separate evaluations, just where do you start with planning for the engagement? How do you complete the necessary risk and control documentation that you will need to successfully complete the engagement? Attend this webinar to learn more. Areas...
Post a Comment
Read more

Essentials of Affirmative Action and OFCCP Compliance

Compliance Key INC  -  Human Resource Training Online                                                                  Janette Levey Frisch Janette Levey Frisch is Keynote Speaker at Compliance key Inc. She is founder of  The EmpLAWyerologist Firm, has over 20 years of legal experience, more than 10 of which she has spent in Employment Law. It was during her tenure as sole in-house counsel for a mid-size staffing company headquartered in Central New Jersey, with operations all over the continental US, that she truly developed her passion for Employment Law.   Webinar Id:   CICJE001  10.00 AM PT | 01.00 PM ET   01/09/2018  Duration: 90 mins  Overview If you are a federal contractor, having a firm grasp on the essentials ...
Post a Comment
Read more

The 5 most Dangerous Risks Under New HIPAA Laws

Compliance Key  -   Online hipaa training for employees in US Overview This 90-minute webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018. We will go into detail about the 5 biggest "gotcha's" related to compliance with this enigmatic law. I will also speak of multiple litigated cases I have been involved with involving HIPAA compliance (or lack there of areas also covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT.  The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers and what you guys need to do and how to best im...
Post a Comment
Read more