What is it all about?
Join us for an insightful webinar on CCDS Implementation: Practical Strategies for Local Regulatory Labeling Alignment. This webinar will introduce you to the essentials of the Company Core Data Sheet (CCDS) and its fundamental role in ensuring Regulatory labeling alignment, highlighting the critical importance of local compliance across markets.
We will explore practical strategies for implementing CCDS in local labeling, along with an overview of the current Regulatory landscape across the EU, US, and MoW. Gain a deeper understanding of local labeling requirements, as well as the challenges and opportunities in achieving effective CCDS alignment and look ahead at the future trends shaping this field.
The webinar will be hosted by Neha Ahuja and presented by Michael Lambell. During the webinar, our experts will discuss the following:
- Introduction to CCDS
- What is local labeling?
- Implementation of CCDS in local labeling
- Local Regulatory landscape in the EU, US, and MoW
- Region-wise labeling requirements
- Challenges and opportunities
- Future trends in CCDS Implementation
Given the keynotes and with due respect to your busy schedule, we look forward to seeing you at the webinar. Register now!
Neha is a Chemist by training and has over thirteen years of experience working in the Analytical & Clinical Science research laboratories and in Regulatory Affairs. At Freyr, Neha leads Project Management and Transitions for multiple projects with various Regulatory agencies and supports clients seeking Regulatory compliance in the US, ROW, and EU markets. She has led various scientific operations and marketing projects in the Consumer, Taevas, Medical Writing and MPR delivery segments. Neha also supports Freyr’s Medical Writing and Communications domain and their technical marketing initiatives.
Michael has over 40 years of industry experience. He has worked in Regulatory roles (predominantly CMC Regulatory functions) for 31 years, and 11 years in other scientific development roles (including formulation development and analytical method development) at Eli Lilly and Johnson & Johnson. His experience includes managing collaborations with Regulatory partner companies. With this extensive experience, he is currently leading a range of Regulatory programs at Freyr.
Host
Neha Ahuja
Senior Manager
Speaker
Michael Lambell
Senior Vice President

