2025-09-30 2025-09-30 , online online, 1,290 € zzgl. MwSt. EU Regulatory Strategy

This intensive seminar provides strategic insights into EU regulatory affairs. With updates on the new EU pharmaceutical legislation, you'll understand the regulatory framework for all important strategic decisions. Learn how to align your regulatory strategy with corporate goals, collaborate successfully with other departments & authorities, and use tools like RIMS effectively.

Themen
  • Strategic position of regulatory affairs within your organisation
  • Cross-functional collaboration with R&D, PV, market access, QA, supply chain and more
  • Methods & tools for strategic planning
  • Regulatory framework: The new EU pharmaceutical legislation
  • RIMS and structured data for regulatory strategy and strategic alignment


Who should attend
This seminar is aimed at regulatory affairs professionals and adjacent roles who contribute to or are responsible for regulatory strategy. It can also be relevant for all other departments involved in regulatory planning such as market access, business development and marketing.

Participants are expected to have a solid understanding of EU regulatory procedures.
Ziel der Veranstaltung
This intensive seminar offers a comprehensive overview of strategic regulatory planning. From foundational principles to hands-on tools, all key aspects of regulatory strategy will be addressed - including authority coordination, project planning, and structured data use.

You will learn how to position regulatory affairs as a core strategic function within your organisation and how to enhance its impact through cross-functional collaboration and digital solutions. You will also explore how the revised EU pharmaceutical framework will impact your regulatory strategy and how to us use regulatory information management systems (RIMS) for strategic data use.

At the end of the training, you will be equipped with essential methods and insights to develop and implement your own successful regulatory strategy.
Teilnehmerkreis

  • You gain a practical understanding of the evolving EU regulatory landscape and its implications for your regulatory strategy.
  • You learn how to strengthen the role of regulatory affairs through collaboration with other departments.
  • You gain hands-on knowledge about practical tools for planning and monitoring regulatory activities.
  • You discover how RIMS and structured data can support global strategic decision-making.

EU Regulatory Strategy

EU Regulatory Strategy

From Development to Approval - Strategic Planning in a Changing EU Framework

Benefits
  • Regulatory strategy in the EU context
  • Update on new EU pharmaceutical legislation
  • Practical tools and methods for your strategy
  • Officially certified according to ISO 9001 and ISO 21001

Webcode 25122602

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Termin

10/12/2025

10/12/2025

Zeitraum

9:00-17:00 CET - online seminar
You may dial in 30 minutes before the training starts

9:00-17:00 CET - online seminar
You may dial in 30 minutes before the training starts
Veranstaltungsort

online

online

Gebühr
Your contact

Jean-Marie Bayhurst
Conference Manager

+49 6221 500-685
j.bayhurst@forum-institut.de

Details

This intensive seminar provides strategic insights into EU regulatory affairs. With updates on the new EU pharmaceutical legislation, you'll understand the regulatory framework for all important strategic decisions. Learn how to align your regulatory strategy with corporate goals, collaborate successfully with other departments & authorities, and use tools like RIMS effectively.

Themen

  • Strategic position of regulatory affairs within your organisation
  • Cross-functional collaboration with R&D, PV, market access, QA, supply chain and more
  • Methods & tools for strategic planning
  • Regulatory framework: The new EU pharmaceutical legislation
  • RIMS and structured data for regulatory strategy and strategic alignment


Who should attend
This seminar is aimed at regulatory affairs professionals and adjacent roles who contribute to or are responsible for regulatory strategy. It can also be relevant for all other departments involved in regulatory planning such as market access, business development and marketing.

Participants are expected to have a solid understanding of EU regulatory procedures.

Ziel der Veranstaltung

This intensive seminar offers a comprehensive overview of strategic regulatory planning. From foundational principles to hands-on tools, all key aspects of regulatory strategy will be addressed - including authority coordination, project planning, and structured data use.

You will learn how to position regulatory affairs as a core strategic function within your organisation and how to enhance its impact through cross-functional collaboration and digital solutions. You will also explore how the revised EU pharmaceutical framework will impact your regulatory strategy and how to us use regulatory information management systems (RIMS) for strategic data use.

At the end of the training, you will be equipped with essential methods and insights to develop and implement your own successful regulatory strategy.

Teilnehmerkreis

  • You gain a practical understanding of the evolving EU regulatory landscape and its implications for your regulatory strategy.
  • You learn how to strengthen the role of regulatory affairs through collaboration with other departments.
  • You gain hands-on knowledge about practical tools for planning and monitoring regulatory activities.
  • You discover how RIMS and structured data can support global strategic decision-making.