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Identification of Medicinal Products (IDMP) – Building a Compliance-Driven Pilot Program
This Webinar is over| Date | Dec 13, 2016 |
| Time | 01:00 PM EDT |
| Cost | $299.00 |
|
Online
|
~Date: December 13, 2016
Time: 1:00pm-2:30pm, EST US
Duration: 90-Minutes
Price: $299 - Includes Bonus Handouts!
~Course Description:
IDMP – an acronym for IDentification of Medicinal Products is a collection of 5 ISO standards which will be used across Life Sciences to structure the standard reporting of information across companies and to regulatory agencies. IDMP is the next phase of the xEVMPD standards put in place in 2012. The EU is the first region that will require IDMP compliance starting in 2018-2020 with other countries also planning to implement the standards (US, Japan, Canada) not long after.
Compliance with IDMP will not be easy. Iterations 1-4 of IDMP will require accurate capture of over 500 discrete data elements per product. Most companies are planning to use Master Data Management (MDM) for eventual IDMP compliance but first, these elements need to be found, mapped, and have any gaps identified. This is why an IDMP Pilot program is an excellent way to get started toward IDMP compliance.
An IDMP Pilot Program will:
Populate full IDMP data elements for a small subset of your total # of SKUs (3-5 Products)
Find where data resides – in structured, semi-structured, and unstructured sources
Determine the authoritative source of data elements if multiple versions are found
Identify hard gaps in your product information that will need to be created or sourced
Give you an accurate estimate of the cost and level of effort needed to reach full IDMP Compliance
By attending this interactive, 90-minute live session, you and your colleagues will learn:
The best ways to evaluate your current data structure for compliance
To identify risks and prepare for compliance
The significant compliance milestones to look for
About tools and activities that will ensure you are prepared for any outcome
Who Should Attend
This course will be of benefit to anyone involved in compliance with current EU xEVMPD rules as well as well as IT and compliance executives and managers who will soon be responsible for IDMP compliance.
Instructor Bio
Tom Beatty has recently completed a successful IDMP Pilot project for a Fortune 50 Pharmaceutical manufacturer.
Prior to his work on IDMP, Tom spent the previous 4 years working on Unique Device Identification (UDI) projects for medical device clients. Tom has published two articles in MD+DI about key steps and strategy for UDI serialization and compliance.
Mr. Beatty spent over 5 years in the Life Sciences practice of Deloitte Consulting, and began his career in life sciences as the Operations Manager in charge of product supply and pricing for a Wyeth-Ayerst’s Middle-East and North Africa and European markets. He is a dual US/EU national. Mr. Beatty has a BBA from the University of Notre Dame.
Time: 1:00pm-2:30pm, EST US
Duration: 90-Minutes
Price: $299 - Includes Bonus Handouts!
~Course Description:
IDMP – an acronym for IDentification of Medicinal Products is a collection of 5 ISO standards which will be used across Life Sciences to structure the standard reporting of information across companies and to regulatory agencies. IDMP is the next phase of the xEVMPD standards put in place in 2012. The EU is the first region that will require IDMP compliance starting in 2018-2020 with other countries also planning to implement the standards (US, Japan, Canada) not long after.
Compliance with IDMP will not be easy. Iterations 1-4 of IDMP will require accurate capture of over 500 discrete data elements per product. Most companies are planning to use Master Data Management (MDM) for eventual IDMP compliance but first, these elements need to be found, mapped, and have any gaps identified. This is why an IDMP Pilot program is an excellent way to get started toward IDMP compliance.
An IDMP Pilot Program will:
Populate full IDMP data elements for a small subset of your total # of SKUs (3-5 Products)
Find where data resides – in structured, semi-structured, and unstructured sources
Determine the authoritative source of data elements if multiple versions are found
Identify hard gaps in your product information that will need to be created or sourced
Give you an accurate estimate of the cost and level of effort needed to reach full IDMP Compliance
By attending this interactive, 90-minute live session, you and your colleagues will learn:
The best ways to evaluate your current data structure for compliance
To identify risks and prepare for compliance
The significant compliance milestones to look for
About tools and activities that will ensure you are prepared for any outcome
Who Should Attend
This course will be of benefit to anyone involved in compliance with current EU xEVMPD rules as well as well as IT and compliance executives and managers who will soon be responsible for IDMP compliance.
Instructor Bio
Tom Beatty has recently completed a successful IDMP Pilot project for a Fortune 50 Pharmaceutical manufacturer.
Prior to his work on IDMP, Tom spent the previous 4 years working on Unique Device Identification (UDI) projects for medical device clients. Tom has published two articles in MD+DI about key steps and strategy for UDI serialization and compliance.
Mr. Beatty spent over 5 years in the Life Sciences practice of Deloitte Consulting, and began his career in life sciences as the Operations Manager in charge of product supply and pricing for a Wyeth-Ayerst’s Middle-East and North Africa and European markets. He is a dual US/EU national. Mr. Beatty has a BBA from the University of Notre Dame.
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