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Informa
Starting 8-17 September

LIVE Online Course - 4 sessions

Gain an understanding of the practical requirements for biopharm CMC studies to support strategic decisions, budgets and timeframes

For biotech and biosimilar products

Course Overview

This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful design, implementation and documentation of the required CMC analytical and stability studies for biotechnology products, including biosimilar products. Key deliverables from each phase of development will be illustrated. Current ‘hot-button’ CMC analytical and stability issues will be presented, and strategies for preventing (or remediating) gaps will be presented.

Live Online Academies

Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-3.5 hours online.

Over 2 weeks students will learn through:

  • Live interactive bitesize sessions
  • Direct interaction with the trainer during live sessions
  • Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
  • Revisiting recorded sessions with unlimited access for 30 days
  • Interaction with peers during live sessions and through the online forum

Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact lifesciences-training@informa.com.

What will you learn?


Phase-specific requirements
Phase-specific requirements

Gain a comprehensive overview of the phase-specific requirements for CMC analytical characterisation, comparability, release and stability of biotechnology products

Product life cycle
Product life cycle

Examine the different stages of the life cycle including pre-clinical, clinical trials, commercialisation and post-approval

Analytical considerations
Analytical considerations

Discuss analytical considerations for a wide variety of biopharmaceuticals including monoclonal antibodies, therapeutic proteins, gene therapy, vaccines, and complex products (e.g. antibody drug conjugates)


Product reference standards
Product reference standards

Maintain product reference standards and design successful comparability tests

Comparability tests
Comparability tests

Design and implement successful comparability tests for biosimilars

Product specifications
Product specifications

Learn to set meaningful product specifications, conduct forced degradation studies and manage tech transfer


Methods and protocol
Methods and protocol

Bridge changes in analytical methods and generate effective stability protocols

Lab quality practices
Lab quality practices

Assess critical elements of laboratory quality practices that significantly impact the reliability of test data from R&D through to current GMP will be illustrated

Who is this course for?

This training course is intended for professionals who are involved with stability testing for biotechnology products, directly or indirectly. Professionals from Pharmaceutical, Biotechnology, Drug Delivery and Medical Device companies should attend, such as, but not limited to:

  •  Stability Directors/ Supervisors/Managers/Analysts/Coordinators
  • Laboratory Supervisors/ Managers
  • Project Managers/Coordinators
  • Quality Control Analytical Chemists
  • Research and Development Chemists
  • Biostatisticians
  • LIMS Administrators
  • QA/QC Reviewers
  • Validation Scientists
  • Calibration/Metrology Groups
  • Internal or Independent Auditors
  • Manufacturing/Production Managers

The analytical side of CMC with course leader, Nadine Ritter


Nadine Ritter, President and Analytical Advisor at Global Biotech Experts, discusses how shortening timelines are impacting the analytical side of chemistry, manufacturing, and control (CMC).

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.