CMC/Regulatory Affairs for Nucleic Acids (US)
CMC/Regulatory Affairs for Nucleic Acids (US)

Course Description

This intensive 3-day course provides a deep dive into the critical aspects of Chemistry, Manufacturing, and Controls (CMC) and Regulatory Affairs in the development of nucleic acid therapeutics. Participants will gain a thorough understanding of the quality requirements, regulatory expectations, and best practices necessary to navigate the complex landscape of nucleic acid drug development.

  • Regulatory Frameworks and Guidelines
  • CMC Strategies for Nucleic Acid Therapeutics
  • Quality Control and Assurance
  • Manufacturing Processes and Facilities
  • Analytical Methods and Characterization
  • Stability Studies and Comparability Assessments
  • Post-Approval Changes and Lifecycle Management
    Risk Management and Compliance
  • Understand the regulatory frameworks governing nucleic acid therapeutics
  • Develop effective CMC strategies to ensure product quality and compliance
  • Implement robust quality control and assurance measures throughout the development lifecycle
  • Gain insights into manufacturing processes and facilities specific to nucleic acid drugs
  • Master analytical methods for characterization and stability assessment
  • Navigate post-approval changes and lifecycle management effectively
  • Mitigate risks and maintain compliance with regulatory requirements

CMC/Regulatory Affairs for Nucleic Acids (US)

18 - 20 June 2024, Live Online Training
€1.850,00
Dr. Len Pattenden

Len has over 30 years of experience in both industry and academia. Len has undertaken development and manufacturing of 18 new biological entities, including first-in-man/first-in-class cell and gene therapies, viral vectors, biologics, and monoclonal antibodies. His regulatory and licensing experience covers the MHRA, EMA and FDA.

START TIMES

11:00 AM New York time

8:00 AM Los Angeles time

4:00 PM London time

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Course Description

This intensive 3-day course provides a deep dive into the critical aspects of Chemistry, Manufacturing, and Controls (CMC) and Regulatory Affairs in the development of nucleic acid therapeutics. Participants will gain a thorough understanding of the quality requirements, regulatory expectations, and best practices necessary to navigate the complex landscape of nucleic acid drug development.

  • Regulatory Frameworks and Guidelines
  • CMC Strategies for Nucleic Acid Therapeutics
  • Quality Control and Assurance
  • Manufacturing Processes and Facilities
  • Analytical Methods and Characterization
  • Stability Studies and Comparability Assessments
  • Post-Approval Changes and Lifecycle Management
    Risk Management and Compliance
  • Understand the regulatory frameworks governing nucleic acid therapeutics
  • Develop effective CMC strategies to ensure product quality and compliance
  • Implement robust quality control and assurance measures throughout the development lifecycle
  • Gain insights into manufacturing processes and facilities specific to nucleic acid drugs
  • Master analytical methods for characterization and stability assessment
  • Navigate post-approval changes and lifecycle management effectively
  • Mitigate risks and maintain compliance with regulatory requirements

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

CMC/Regulatory Affairs for Nucleic Acids (US)

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

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