Count Every Second Until the Event

28
Days
10
Hours
35
Minute
40
Second
2022-03-29 8:00

Course Overview

Maintaining regulatory compliance for marketed drug products is a major task in all pharmaceutical companies. This task can create around 70% of the workload of regulatory affairs departments. It is business-critical to optimize the entire lifecycle management from R&D over product launch to the marketing phase and even to product discontinuation. Conflicts, mostly resulting from different approaches and priorities, can have negative impact on business processes even outside the R&D or GMP areas.

This masterclass describes current requirements how a baseline CMC dossier should be developed based on a solid and robust knowledge fundament on the drug product. Knowing the factors impacting product quality will enable the entire company to set up a transparent and well-structured lifecycle management, ensuring regulatory compliance and saving time and money.

Why join the event

Key takeaways of the program

Understand the different purpose and scope of GMP documents and regulatory documentation.

What are the different levels of detail in CMC versus GMP documentation?

An understanding of the changing capital requirement and what this means for risk management and governance.

Understand the concept of Quality by Design development for APIs and finished products.

How should manufacturing processes be described in the CMC dossier compared to the GMP documents? What level of detail is required and recommendable?

How will new and upcoming guidelines impact our business?

Understand how quality risk management according to ICH Q9 should support product lifecycle from baseline CMC to variations.


What are key activities to ensure regulatory compliance?

Who Should Attend

An event precisely for you

Heads of R&D
Heads of R&D
Heads of QC & QA
Heads of QC & QA
Manufacturing Heads
Manufacturing Heads
Heads of Drug Regulatory Affairs
Heads of Drug Regulatory Affairs
Pharmaceutical Development Managers
Pharmaceutical Development Managers
Product Maintenance Managers
Product Maintenance Managers

The speaker

Meet your trainer

During more than 30 years of professional experience in the pharmaceutical industry, Helmut held senior positions in QC, Project Management, Regulatory Affairs, Pharmaceutical Development and Quality Assurance. He worked for 3 years in India to set up a pharmaceutical development center for ratiopharm GmbH as a greenfield project.Since 2016 he is supporting the pharmaceutical industry as an independent consultant in the areas of Drug Regulatory Affair, Quality Assurance and as QP. Due to his in-depth experience in R&D as well as the GMP area, he perfectly knows the challenges and opportunities at the interface between these fields. Additionally, he acts as a visiting lecturer at different universities teaching Drug Regulatory Affairs.

Dr. Helmut Vigenschow

Dr. Helmut Vigenschow

Senior Pharmaceutical Consultant and Founder
ViPharmaService

The Curriculum

What you’ll get from this exclusive event

Fresh Content

Knowledge is only useful when it is relevant. This event is based on the latest research, best practices and industry information. As a result, we close events with a strong knowledge base that helps achieve same-day results.

Networking

Meet and collaborate with like-minded professionals across the globe. Grow your professional network, exchange ideas, and learn more about the industry with your own peers, together.

Experience

Experience comes with practice, and this event will guide you on the right path in becoming a well renowned expert in your field. You will learn through a combination of lecture-based content, real-life case studies, and a more hands-on experience.

Q&A Session

By joining this class, you will be given the opportunity to constantly engage with your peers and raise your concerns, questions, or doubts you may have pertaining to the subject. And, receive well-founded, well-thought-out answers to your every need by leading experts in the industry. 

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