|Webcasts|December 10, 2019

Transforming Regulatory Affairs: Sharing Industry Peer Perspectives

Author(s)IQVIA

Regulatory requirements continually change, requiring the use of new innovative approaches, including technology advancement and process automation. Join us and take advantage of lessons learned from your peers to eliminate bottlenecks and leverage up-to-date regulatory intelligence to mitigate risks. Live: Tuesday, Dec. 10, 2019 at 11am EST On demand available after airing until Dec. 10, 2020. Register free

Register free: http://www.appliedclinicaltrialsonline.com/act_w/perspectives

Event Overview:

The Global Regulatory environment needs to evolve to reflect changing industry dynamics. Emerging markets are increasing expectations on regulatory documentation while regulators are demanding more information and greater data consistency both pre- and post-approval. There is an increased emphasis on compliance, inclusive of regulatory, safety and quality requirements for marketed products.

Listen to case studies on how innovative approaches are automating processes and delivering end-to-end regulatory data integration solutions. Use cases and lessons learned include:

  • Regulatory submission services, including pre-IND, IND and publishing services

  • Advanced RIM systems to eliminate bottlenecks and leverage up-to-date regulatory intelligence before costly mistakes are made

  • Global lifecycle maintenance strategies for established products

  • Divestment and acquisition support

Register today and hear how companies are transforming their regulatory affairs and realizing the benefits of integrating their safety, regulatory and quality approaches for more efficient and predictable solutions!

Key Learning Objectives:

Increase quality and compliance, while decreasing complexity by leveraging regulatory expertise and advanced technology capabilities

Take advantage of lessons learned from your peers to eliminate bottlenecks and leverage up-to-date regulatory intelligence to mitigate risks before costly mistakes are made

Scalable for customers of all sizes through global network with local hubs

Speakers: Kelly Poole, Senior Director, Global Regulatory Affairs, IQVIA

Wendy Scott, Senior Director, Global Regulatory Affairs, IQVIA

Time and date: Tuesday, Dec. 10, 2019 at 11am EST

On demand available after airing until Dec. 10, 2020.

Sponsor: IQVIA

Register free: http://www.appliedclinicaltrialsonline.com/act_w/perspectives


Related to this article

The Human Side of Clinical Trials: How Measuring Readiness at Training Predicts Trial Risk Before It Shows Up in the Data
This episode of The Human Side of Clinical Trials, hosted by Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., and Kelly Ritch, chief operating officer of ArcheMedX, Inc., explores why training completion metrics like attendance and quiz scores fail to capture true study readiness, and how measuring both competence and confidence can reveal trial risks before enrollment even begins.
What the Epilepsy Community Has Taught Us About Trial Feasibility
In this video interview, Amélie Lothe, global medical community head for rare epilepsies at UCB Pharma, shares what she has learned firsthand from families living with Dravet syndrome and CDKL5 deficiency disorder about what makes trial participation possible—and what makes it not.