Introduction

The Masterclass is intended to help you dive deep into the design and execution of the major CMC analytical studies. This will be opened by an overview of maintaining regulatory compliance for marketed drug products along with a special focus on how new and upcoming guidelines will impact your businesses. Important activities to ensure regulatory compliance and how approvable specifications for API's and finished products be drafted will be discussed, along with additional sessions on how facing tough challenges in CMC dossier preparation, followed by a discussion on how quality risk management according to ICH Q9 should support product lifecycle from baseline CMC to variations and much more.

This is a live, two-day masterclass limited to a selected set of participants across Europe & UK and will be conducted by seasoned regulatory affairs expert and lecturer, Dr. Helmut Vigenschow who holds more than 30 years of experience in the Pharmaceutical sector.

An exclusive discount of 20% is available for RSC members valid until 31/01/2021

Deadlines

• Dec 31 2021
  Early bird registration deadline

  
• Jan 31 2022
  20% discount for RSC Members deadline

  

Useful links

• Further event details More information about the event

Speakers

• Dr. Helmut Vigenschow Senior Pharmaceutical Consultant and Founder ViPharmaService, Germany

  https://www.linkedin.com/in/helmut-vigenschow-25b5813a/

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Venue

Online: live, instructor-led virtual classroom training

Online: live, instructor-led virtual classroom training, United Kingdom

Organised by

At Keynotive, we are on a mission to connect you with remarkable individuals and provide invaluable insight for every business domain. We help professionals and organizations achieve a new level of success through innovative learning and networking opportunities that they can’t access otherwise. We work with the most influential industry experts and plan, design, and organize impactful and pragmatic learning experiences whilst creating opportunities for professionals and thought leaders to collaborate. Our aim is to enable professionals to explore and discuss current industry affairs, connect, share knowledge, find solutions and spark conversations. Simply put, we offer the perfect opportunity to reach the next level in your career.

We value outcomes more than anything and always approach everything we do by keeping our customers at heart. We strive for the best learning outcomes while making our events engaging, interactive and rich from start to finish. With a skilled team and over 20 years of experience in event management, we ensure quality and value in everything we do paying attention to every little detail.

Keynotive

Contact information

Sam Jones
Keynotive
+44 204 511 6926
Contact us by email

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