FORUM INSTITUT
FORUM · Institut für Management GmbH
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69115 Heidelberg
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Course eCTD Life Cycle Management - National and Global
eCTD Life Cycle Management -
National and Global
2020-02-27 2020-02-27 HYPERION Hotel München Truderinger Str. 13 81677 München +49 89 411090-0 +49 89 411090-1000

eCTD Life Cycle Management - National and Global

Integration of national requirements in global life cycle management

National dossier requirements and global life cycle management: How do they fit together? This course provides practical tips on how to professionalise your electronic dossier submission and life cycle management.
Topics
  • eCTD requirements in Europe, the US and the ICH region
  • Electronic submission requirements in LATAM, ASEAN, the Middle East and Africa
  • Life cycle management: dealing with line extensions, new manufacturers, etc.
  • Challenges of parallel submissions and splitting procedures
  • Master data concept and core dossier

Aims and objectives

This seminar will address peculiarities both in developing and submitting an eCTD within the ICH region and in global eSubmission requirements. It will make you aware of the duties involved in applying for a marketing authorisation in the ICH region and in LATAM, ASEAN, the Middle East and Africa.

It will also make you especially knowledgeable of your life cycle management duties and provide best-practice tips on how to integrate national requirements in your global life cycle management.

Ultimately, it will show you how to optimise your regulatory operations and IT support.

Who should attend
This seminar addresses the needs of regulatory and medical affairs personnel in the pharmaceutical industry who intend to submit and manage marketing authorisation dossiers within and beyond the ICH region.

Prior knowledge of the ICH eCTD is required.
Your speakers
Frank Dickert
EXTEDO GmbH, Ottobrunn, GERMANY

Dr. Vicente Tur
ASPHALION S.L., Barcelona, SPAIN


Go forward

Pharma Webcast Global RA & PV

Pharma FORUM Webcast International

We would like to invite you to join our live webcasts, where local regulatory affairs and vigilance experts will inform you every two months of the latest news and trends in global marketing authorisation and drug safety.

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e-Learning

e-Learning - Click and learn

The FORUM · Institut für Management GmbH provides flexible education and training with high-quality e-Learning programmes for several topics.

You can access top expertise from anywhere.

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More on our quality criteria

Quality guaranteed!

IMI (Innovative Medicines Initiative) defined quality criteria for professional training and education. We follow these criteria and, as a signatory, we are an active partner in further developing and optimising the quality standards.

An aggregate evaluation of participants' feedback on all FORUM's healthcare training courses (evaluation period from 10.2017 - 09.2018 produced a result of 1.6 (based on a school grading system of 1-6).

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