2025-03-31 2025-03-31 , online online, 1,290 € zzgl. MwSt. Andreas Renneis https://forum-institut.de/seminar/25082260-quality-management-and-process-optimization-in-medical-affairs/referenten/25/25_08/25082260-quality-management-and-process-optimization-in-medical-affairs_renneis-andreas.jpg Quality Management and Process Optimization in Medical Affairs

We will focus on how to integrate compliance and governance into Medical Affairs activities and ensure quality documentation that is both effective and pragmatic.

Topics
  • Compliance & Business Process Management (BPM) in Medical Affairs
  • Business Process Management & Quality Documentation in Medical Affairs
  • Governance and Management in Clinical Trials, NIS, IIS and Patient Programs
  • Audit preparation and coordination
  • Workshop: Process and Documentation Optimization in Medical Affairs


Who should attend
This seminar is designed for professionals working in Medical Affairs who are involved in quality management, compliance, or process optimization. It is also suitable for colleagues from Clinical Operations, Regulatory Affairs, or related departments who collaborate closely with Medical Affairs teams.
Aims and objectives
Efficient quality and process management is essential in today's Medical Affairs environment. This interactive online seminar offers practical insights into how to structure and optimize business processes while meeting regulatory expectations and internal quality standards. Gain a comprehensive understanding of Business Process Management (BPM) tailored to the Medical Affairs function, and learn how to integrate compliance, governance, and documentation in a practical, non-bureaucratic way. We will also focus on clinical trials, NIS, IIS, and patient programs - where process clarity and documentation quality are critical. Learn how to prepare for audits with confidence and take part in hands-on workshop exercises designed to translate theory into your day-to-day work. Join us for this compact, one-day online training and take your quality and process mindset in Medical Affairs to the next level!
Your benefit

  • You will gain actionable insights into how to manage business processes within Medical Affairs effectively.
  • You will learn how to reduce complexity and ensure regulatory compliance without overburdening your teams
  • You will understand how to align documentation practices with internal and external expectations.
  • You will receive concrete strategies for audit preparation and cross-functional communication.

Structuring business processes, ensuring quality documentation and compliance

Quality Management and Process Optimization in Medical Affairs

Structuring business processes, ensuring quality documentation and compliance

Benefits
  • Role of BPM tools in Medical Affairs
  • Smart documentation practic
  • Audit-readiness and communication strategies
  • Officially certified to ISO 9001 and ISO 21001 standard

Webcode 25082260

Jetzt buchen

JETZT Buchen

Referent


Alles auf einen Blick

Termin

28/08/2025

28/08/2025

Zeitraum

from 09:00 a.m. until 05:00 p.m.
You may dial in 30 minutes before the session

from 09:00 a.m. until 05:00 p.m.
You may dial in 30 minutes before the session
Veranstaltungsort

online

online

Downloads
Gebühr
Your contact

Cornelia Gutfleisch
Team Leader Pharma & Healthcare

+49 6221 500-694
c.gutfleisch@forum-institut.de

Details

We will focus on how to integrate compliance and governance into Medical Affairs activities and ensure quality documentation that is both effective and pragmatic.

Topics

  • Compliance & Business Process Management (BPM) in Medical Affairs
  • Business Process Management & Quality Documentation in Medical Affairs
  • Governance and Management in Clinical Trials, NIS, IIS and Patient Programs
  • Audit preparation and coordination
  • Workshop: Process and Documentation Optimization in Medical Affairs


Who should attend
This seminar is designed for professionals working in Medical Affairs who are involved in quality management, compliance, or process optimization. It is also suitable for colleagues from Clinical Operations, Regulatory Affairs, or related departments who collaborate closely with Medical Affairs teams.

Aims and objectives

Efficient quality and process management is essential in today's Medical Affairs environment. This interactive online seminar offers practical insights into how to structure and optimize business processes while meeting regulatory expectations and internal quality standards. Gain a comprehensive understanding of Business Process Management (BPM) tailored to the Medical Affairs function, and learn how to integrate compliance, governance, and documentation in a practical, non-bureaucratic way. We will also focus on clinical trials, NIS, IIS, and patient programs - where process clarity and documentation quality are critical. Learn how to prepare for audits with confidence and take part in hands-on workshop exercises designed to translate theory into your day-to-day work. Join us for this compact, one-day online training and take your quality and process mindset in Medical Affairs to the next level!

Your benefit

  • You will gain actionable insights into how to manage business processes within Medical Affairs effectively.
  • You will learn how to reduce complexity and ensure regulatory compliance without overburdening your teams
  • You will understand how to align documentation practices with internal and external expectations.
  • You will receive concrete strategies for audit preparation and cross-functional communication.

Detailed programme

from 09:00 a.m. until 05:00 p.m.
You may dial in 30 minutes before the session

Welcome and introduction


Compliance & Business Process Management (BPM) in Medical Affairs
  • Medical Affairs in the area of conflict between commercialization and R&D
  • Specific requirements in Medical Affairs / compliance with regulatory and other external requirements
  • Medical Affairs as part of a compliance and quality document management system
  • Medical Governance in Medical Affairs

Coffee break


Business Process Management & Quality Documentation in Medical Affairs
  • Introduction to Business Process Management / What is in for me?
  • Process Mapping and Optimization
  • Process Management & Process Documentation
    • Bureaucratic Monster or real help?

Lunch break


Governance and Management in Clinical Trials, NIS, IIS and Patient Programs
  • Best Practices in Medical Clinical Trial Governance/NIS/IIS
    • Catchword 'Fair Market Value'
  • Specific challenges in IIS
Patient Program Requirements

Audit preparation and coordination
  • Internal communication
  • Be Audit-Ready / Behavioral Training

Coffee break


Workshop: Process and Documentation Optimization in Medical Affairs
I would rather intersperse practical exercises / quizzes / "role play" or the like at different points during the training ... What and how exactly

End of seminar


Further information

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Learn more about our online events here.

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All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.
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  • Free technical pre-meeting to start off your training on the right foot

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