2024-11-09 2024-11-09 , online online, 1,290 € zzgl. MwSt. Dr Barbara Briggs https://www.forum-institut.de/seminar/25042611-global-labelling-and-company-core-datasheet-ccds/referenten/25/25_04/25042611-global-labelling-and-company-core-datasheet-ccds_briggs-barbara.jpg Global Labelling and Company Core Datasheet (CCDS)

Attend this seminar to gain in-depth knowledge of the CCDS concept, global labelling requirements, and practical insights into market-specific regulations in the EU and USA.

Topics
  • The CCDS - central element in the labelling process
  • CCDS in product development and throughout the product life cycle
  • Content and structure of the CCDS
  • Implementation of CCDS changes in global/local product information
  • Case studies and regulatory requirements from relevant markets


Who should attend
This seminar is designed for specialists and managers within the pharmaceutical industry. It is particularly beneficial for employees involved in labelling and regulatory affairs for human medicinal products, as it offers a valuable opportunity for exchange with experienced speakers. Additionally, it may be of interest to professionals in the following departments and roles:
  • drug safety
  • medical science
  • research and development
  • graduate programme officers
  • information officers
  • qualified persons (QPs).
Aims and objectives
The Company Core Data Sheet (CCDS) serves as the central reference for all information related to a medicinal product. Any errors made here-whether in content or execution-can impact package inserts worldwide, ultimately affecting the perception and use of the product. Therefore, the CCDS should not be considered in isolation but rather as part of an intricate system, involving close collaboration between all central departments.

In this seminar, you will gain a comprehensive understanding of the CCDS concept and the requirements for global labelling. We will delve into the interrelations between the CCDS, pharmacovigilance, regulatory affairs database systems, and the role of the Qualified Person for Pharmacovigilance (QPPV).

The afternoon workshop, featuring case studies, will provide practical insights into market-specific requirements (with a focus on the EU and USA), regional labelling considerations, and their influence on the CCDS.
Your benefit

After attending this seminar,

  • you will have a thorough understanding of the "Core Labelling" / CCDS concept.
  • you will be able to implement changes in regional labels and the CCDS effectively.
  • you will be familiar with the requirements of the relevant EU and US markets.

Couse Global Labelling and Company Core Datasheet (CCDS)

Global Labelling and Company Core Datasheet (CCDS)

Enhancing efficiency and compliance in global labelling

Benefits
  • CCDS content and structure
  • Regulatory requirements for key markets
  • Includes practical case studies
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25042611

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JETZT Buchen

Referenten


Alles auf einen Blick

Termin

11/04/2025

11/04/2025

Zeitraum

from 09:00 - 17:00 You may dial-in 30 minutes before

from 09:00 - 17:00 You may dial-in 30 minutes before
Veranstaltungsort

online

online

Gebühr
Your contact

Dr. Rebekka Bitsch
Conference Manager

+49 6221 500-565
r.bitsch@forum-institut.de

Details

Attend this seminar to gain in-depth knowledge of the CCDS concept, global labelling requirements, and practical insights into market-specific regulations in the EU and USA.

Topics

  • The CCDS - central element in the labelling process
  • CCDS in product development and throughout the product life cycle
  • Content and structure of the CCDS
  • Implementation of CCDS changes in global/local product information
  • Case studies and regulatory requirements from relevant markets


Who should attend
This seminar is designed for specialists and managers within the pharmaceutical industry. It is particularly beneficial for employees involved in labelling and regulatory affairs for human medicinal products, as it offers a valuable opportunity for exchange with experienced speakers. Additionally, it may be of interest to professionals in the following departments and roles:
  • drug safety
  • medical science
  • research and development
  • graduate programme officers
  • information officers
  • qualified persons (QPs).

Aims and objectives

The Company Core Data Sheet (CCDS) serves as the central reference for all information related to a medicinal product. Any errors made here-whether in content or execution-can impact package inserts worldwide, ultimately affecting the perception and use of the product. Therefore, the CCDS should not be considered in isolation but rather as part of an intricate system, involving close collaboration between all central departments.

In this seminar, you will gain a comprehensive understanding of the CCDS concept and the requirements for global labelling. We will delve into the interrelations between the CCDS, pharmacovigilance, regulatory affairs database systems, and the role of the Qualified Person for Pharmacovigilance (QPPV).

The afternoon workshop, featuring case studies, will provide practical insights into market-specific requirements (with a focus on the EU and USA), regional labelling considerations, and their influence on the CCDS.

Your benefit

After attending this seminar,

  • you will have a thorough understanding of the "Core Labelling" / CCDS concept.
  • you will be able to implement changes in regional labels and the CCDS effectively.
  • you will be familiar with the requirements of the relevant EU and US markets.

Detailed programme

from 09:00 - 17:00 You may dial-in 30 minutes before

Welcome and technical instructions


Dr Annette Wüstholz

The CCDS - central component in the labelling process
  • Definition and strategies
  • Legal framework
  • CCDS in the development phase and during lifecycle
  • Relationship between CCDS, pharmacovigilance and the QPPV
  • Differences to EU-SmPC and USPI

Short break


Dr Barbara Briggs

CCDS contents and structure
  • Company Core Safety Information = CCSI
  • Pharmaceutical form
  • First line and second line indications
  • Prescribing information
  • Dosage, pharmacology ...

Lunch break


Dr Annette Wüstholz

Implementation of CCDS changes in global/local product information
  • Strategies for an efficient global process for CCDS updates and implementation of CCDS changes in global/local product information
  • Challenges and solutions for maintaining harmonized implementation of CCDS changes across different regions

Coffee break


Dr Barbara Briggs

Case studies and requirements from relevant markets
  • Focusing on EU and USA

Seminar end


More information

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