Management Forum Logo

Presented by
Management Forum

Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products Training Course

The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance. This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.

2-3 Mar 2023
+ 2 more dates

Need help?  Enrol or reserve

  • Format: Live online, Classroom
  • CPD: 12 hours for your records
  • Certificate of completion

Overview

The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance.

Information regarding chemistry, manufacturing and controls (CMC) for drugs is an important and detailed section in the dossier to support clinical studies and marketing applications. This data must be updated as more information is gained throughout a drug’s lifecycle.

The quality module of the Common Technical Document (CTD) presents the CMC data in the submission dossier for small and large molecules. Compiling the CMC regulatory material is challenging; however this needs to be completed with efficiency and accuracy to gain fast approval.

This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.

This is a key opportunity to learn from an expert in the field of CMC requirements and compliance, and discuss the complexities involved.

Who Should Attend

  • Regulatory, Quality Assurance and Manufacturing personnel
  • Managers of a CMC area
  • CMC Project Managers
  • Quality Assurance Managers for Biological Products
  • Individuals who are new to drug companies

Enrol or reserve

The Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products course will cover:

Welcome and Introductions

Understanding Biologics

  • Understanding what a Biological Product is
  • Defining ATMPs
  • The difference between small and large molecules

CMC Regulatory Guidelines for Biolgoical Drug Products - Part 1

  • Relevant laws, main guidelines & monographs, specifically for biologics (i.e. ATMP guideline and other relevant guidelines for mRNA products)
  • ICH guidelines specific to different modalities (i.e. recombinant proteins, ATMP0
    • Brief background on ICH (e.g., countries belonging to ICH, full membership, observers etc.)
    • Q1-Q6B (no focus on New Chemical Entities (NCEs))                       
    • Q7-Q12 (requirements due to Q12 revision)  

CMC Regulatory Guidelines for Biological Drug Products - Part 2 (continued)

Understanding the Key CMC Aspects of the Common Technical Document (CTD) - Part 1

  • Quality Overall Summary (QOS)                       
  • Examining the structure and content of the CMC sections – developing a CTD Roadmap
  • Overview of the Drug Substance Sections for biologics                          
  • Examine the linkage to the Drug Product Section                        
  • Examine some basic rules for Q11 development and manufacture of drug substances 
  • Significant differences between EU & US & JP (e.g. P.3.5 FDA expectation)      

Understanding the Key CMC Aspects of the CTD - Part 2 (continued)

CMC Regulatory Requirements During Differenct Stages of Development - Part 1

  • Understand the definition and requirements at different stages of development (early stage, linked to clinical trials) as well as for different modalities (mRNA vs. Cell and gene)                       
    • QbD elements: QTPP, CQA, Process Characterization and Validation, Control Strategy
    • Starting materials: MCB and WCB (monoclonality, characterization, follow-up batch qualification)

CMC Regulatory Requirements During Different Stages of Development - Part 2 (continued)

  • Potency assay: development, inter-assay comparability, critical reagent           
  • Reference standard: Primary & working standard (re- & follow-up qualification)
  • Stability requirements & resulting concept (accelerated development): development batch, technical batch, pre-validation batch, PPQ batches                          
  • Comparability exercise for biologics according to ICH Q5E
    • Extended characterization: early versus late phase development
    • Orthogonal methods

CMC Regulatory Requirements During Different Stages of Development - Part 3 (continued)

  • The Review dimensions of the dossier
  • Clinical stages and linkage to formulation / analytical development
  • Develop strategies to overcome challenges             

Building the Pharmacuetical Sections of the Dossier

  • Examining the importance of development biologics/ATMPs                       
  • Review of the sections on development biologics/ATMPs (P2 and S26)           
  • Understanding the reviewer’s perspective, highlighting methods to ensure we answer the reviewer’s questions                       

Understanding Source Documents

  • Overview of source documents                       
  • Understanding the reviewer’s perspective (Using analytical data as an example)
  • Highlight the needs of internal teams versus external reviewers                       
  • Reviewer's questions to be answered

Change Control for Biological Products

  • Change control and the impact of your dossier
  • The importance of comparability                       
  • Practical exercise on change control

 

Enrol or reserve

Andrew Willis
A Willis Consulting

Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services, where he was head of a team of internal and external regulatory affairs consultants.

He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He had 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He has over 30 years’ pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.

More details

Book Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products Live online/Classroom training

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

2-3 Mar 2023

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 12809

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 26 Jan

View basket 

 
Not ready to book yet?

for 7 days, no obligation

6-7 Jul 2023

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 12810

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 01 Jun

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

View basket 

 
Not ready to book yet?

for 7 days, no obligation

26-27 Oct 2023

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 12811

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 21 Sep

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

United Kingdom

  • Gilead Sciences
  • Gilead Sciences International Ltd
  • Jazz
  • Jazz Pharmaceuticals

Poland

  • Polpharma Biologics

Switzerland

  • Swedish Orphan Biovitrum AG

Enrol or reserve

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy