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.
★★★★★ "The speaker had lots of clarity in his explanations, making the course very easy to follow and under... more (6)"
26-27 June 2025
+ 20-21 October 2025 »
from £1299
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
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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.
Please note, it is recommended that attendees have some experience with Module 3 of the CTD.
This course is part of our Biopharma training courses series which aims to provide up-to-date knowledge on industry best practices and regulations surrounding biopharmaceuticals.
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
This course will cover:
Understanding Biologics
- Understanding what a Biological Product is
- Defining ATMPs
- The difference between small and large molecules
CMC Regulatory Guidelines for Biological 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
Andrew Willis
San Salvatore Training Ltd
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.
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
26-27 June 2025
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)
Timings may be different for each day
Course code 14780
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,087 2,399
Until 22 May
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
20-21 October 2025
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)
Timings may be different for each day
Course code 15020
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,087 2,399
Until 15 Sep
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
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; and apply only when booking multiple delegates on the same date.
Reviews of IPI's Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products training course
The speaker had lots of clarity in his explanations, making the course very easy to follow and understand, even with deep topics.
Feb 29 2024
Bernardo Diaz 
Regulatory Affairs Manager, Bioeq AG
Jun 27 2024
Good webinar, presentation and excellent speakers
Nor Hazwan Ali 
Head of Regulatory Affairs,
Jul 6 2023
The webinar had enough information for anyone to start their CMC biologics career or who is interested to do so. Or even for someone with biologics experience is looking to have additional knowledge and information can attend this training. Andrew's knowledge and experience was proven very well.
Vineet Gavankar 
Manager, Regulatory Affairs, PharmaLex UK Services Limited
Jul 6 2023
The content was thorough. The presentation was informative. The speaker was very knowledgeable, helpful and friendly.
Sheena Singadia
Scientist II, Arecor
Mar 2 2023
Very good
Nadia GHAIETH 
Regulatory Affairs Director, TERIAK
Jul 6 2023
The speaker was very good, the slides were clear and the explanations exhaustive.
Chiara Giaconi 
Global Regulatory Affairs Oncology CMC Manager, Menarini Ricerche S.p.A.
United Kingdom
- Arecor
- Arecor Limited
- CLC Consulting
- Gilead Sciences
- Gilead Sciences International Ltd
- Immunovant
- Jazz
- Jazz Pharmaceuticals
- LIfT BioSciences
- PharmaLex UK Services Limited
Netherlands
- Dechra Pharmaceuticals LLC
- HAL Allergy
- Janssen Vaccines & Prevention BV
- Johnson & Johnson
- Prothya Biosolutions Netherlands B.V.
- The European Medicines Agency (EMEA)
- uniqure
Switzerland
- Bavarian Nordic Berna GmbH
- Bioeq AG
- Swedish Orphan Biovitrum AG
France
- Pharmalex France
- SERB Pharmaceuticals
Germany
- BioNTech SE
- Pharmaceutical Research Associates GmbH
Italy
- Chiesi Farmaceutici SpA
- Menarini Ricerche S.p.A.
Poland
- Polpharma Biologics
- Theramex HQ UK Limited
Spain
- Grifols
- Grifols S.A.
Australia
- Private Individual
Denmark
- Ferring Pharmaceuticals A/S
Ethiopia
- Armauer Hansen Research Institut
Slovenia
- Billev farmacija vzhod
Sweden
- SDS Life Sience
Tunisia
- TERIAK
Run Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products Live online for your team
2 days
Typical duration
Pricing from:
- GBP 1,000
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
