New Webinar Series on Global Serialization

Six months ago, Dirk Rodgers and I did a webinar series of DSCSA. Hundreds of pharmaceutical professionals attended the webinars and hundreds more watched the archive. Much has happened in the last six months. EU published the draft Delegated Act while Brazil suspended the data reporting for the required three serialized lots. That’s why I decided to do another three parted webinar series focused on global markets and the expanding landscape of serialization.
This webinar series will give you an update on various country regulations, their requirements, and their deadlines. The registration is currently open for all three webinars. They include:

Global Serialization 1 of 3: Global Serialization Overview 
(Thu, Oct 29, 2015, 11 am Eastern Time)

​​With some deadlines behind us, some approaching, and many more on the horizon, we’ll take a look of the global serialization landscape including that of Brazil, China, South Korea, US, EU and many more. Join this webinar to discuss the lessons learned from past implementations and learn the upcoming deadlines and what they entail.

  • ​Global Regulations
  • Past deadlines
  • Upcoming requirement and deadlines
  • Key implementation building blocks
  • Lessons learned

Register for Event

 

Global Serialization 2 of 3: A Closer Look at US DSCSA
(Thu, Nov 12, 2015, 11 am Eastern Time)

The US DSCSA regulation phases in gradually more difficult requirement as time passes. Its 2015 requirement of product tracing including TI/TH/TS had the industry scrambled to system upgrades and implementations approaching the deadline. The next requirement is serialization which becomes effective in 2017. We’ll take a look of the overall 2017 regulatory requirement and evaluate the wholesale distributors’ positions. The later could be more stringent than the former.

  • DSCSA 2015 review
  • DSCSA 2017 requirement
  • Business requirement from wholesale distributors
  • Make the decision to aggregate
  • Verifications and reporting

Register for Event

 

Global Serialization 3 of 3: A Closer Look at EU Falsified Medicines Directive 
(Thu, Dec 3, 2015, 11 am Eastern Time)

EU Falsified Medicines Directive (FMD) became effective in 2013 bringing in all 28 countries under one unified rule of supply chain security. FMD called for the “Delegated Act” to define the technical specifications of serialization and track-n-trace. The draft of the Delegated Act was published in August 2015 spelling out very detailed rules of implementation for the industry. Join this webinar to learn the EU requirement and its deadlines.

  • Manufacturers’ requirement
  • Wholesale distributors’ requirement
  • EU-Hub and Data reporting
  • Decommissioning
  • Exceptions handling
  • Verifications and reporting

Register for Event