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Sheraton Pentagon City Hotel

2024 年 03 月 14 日 7:30 上午 - 2024 年 03 月 15 日 4:15 下午

900 South Orme Street, Arlington, VA 22204, USA

Global Labeling Conference

Join speakers from around the world sharing their labeling – Germany, Japan, Belgium, UK, Canada and more!

Hosted Session/Non-CE: Case Study Spotlight hosted by IQVIA: Ensuring Labeling Harmonization Amidst a Legal Entity Change

Session Chair(s)

  Sponsored Sessions

Sponsored Sessions

United States

The success and safety of drug products heavily depend on an efficient labeling team, particularly during a legal entity change such as a merger, acquisition, or marketing authorization transfer. Such changes can pose compliance risks, leading to potential safety risks, product recalls, and brand damage. However, the development of new labels can be smooth with a well-planned strategy, timeline, and data transfers that follow both companies’ regulations.

Successful labeling harmonization relies on a gap analysis that examines the labeling practices of both companies and identifies any discrepancies. This allows for the creation of a strategy that addresses these deviations and mitigates any compliance risk. If the labeling team lacks the ability to manage this additional workload, partnering with a vendor experienced in legal entity change procedures could be beneficial. The process begins with reviewing the steps to develop new, compliant labels, followed by identifying a strategy that aligns with the company’s goal with a patient-centric approach.

Featured Topics:

  • Impact Assessment and Gap Analysis
  • Designin a Labeling Strategy
  • Data Transfer
  • Submission to Health Authorities
  • New Label Implementation
  • Using LLM, NLP, and Automated Label Text Comparison Technology

Speaker(s)

Rama Mohan Rao  Chikkam

Rama Mohan Rao Chikkam

IQVIA, United States

Senior Director, Regulatory Affairs

Kiran  Chinnalla

Kiran Chinnalla

IQVIA, India

Director, Product Manager - Regulatory Affairs

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