Introduzione
Biologics manufacturing is a complex procedure, and it takes time and effort.
Some points need to be considered and addressed.
- The biological molecule itself is complex and inherently heterogeneous in nature (very different from the small molecules).
- Biologics (and biosimilars) are produced by living cells in a very complex process with several critical steps.
- It is almost impossible to guarantee that each batch of biologics is identical to the previous one. Nonetheless, manufacturers are required to have as much control over the process as possible to identify and manage unexpected variations which may affect product quality, efficacy, and safety.
Balancing the technical aspects of biologics manufacturing and characterisation with the essential regulatory requirements is a challenging objective that requires multidisciplinary teams.
Good process and product knowledge and control must be properly demonstrated to obtain approval for clinical trials and market entry.
With a clear understanding of the specific nature of biologics (in particular monoclonal antibodies, vaccines and insulins), and based on regulatory guidance and discussion of case studies, this course aims to explain the regulatory basics to all professionals involved in achieving an effective and compliant Module 3 for biologics and biosimilars, accelerating the clinical trials and marketing authorisation process in Europe. The course focuses mainly on the requirements in Europe and explains some of the differences with the USA.
- Introduction and history of biologics and biosimilars
- Current regulatory landscape in EU and US, highlighting the differences and preparing to avoid negative impact on global manufacturing and control
- An overview of the challenges related to biologics development, manufacturing and characterization: insights into reconciling regulatory requirements and technical difficulties in the production process and analytical methods
- Common regulatory findings: case studies discussion to avoid non-conformities
- What do the authorities expect in the description of manufacturing characteristics and manufacturing variations? Activities and documentation to be carried out and presented in Module 3 by the production, quality control, quality assurance and chemistry, manufacturing and control (CMC) departments.
- Definition of biosimilarity and biocomparability: product-specific biosimilar guidelines to keep in mind
- Characterization of biosimilars with respect to the originator molecules: the great initial analytical effort to get a smoother clinical commitment
- An overview of the registration pathways for biosimilars in EU and US for non-regulatory personnel
Personnel working in and with CMC, manufacturing/analytical method development and validation areas, who are interested in knowing regulatory requirements for biologics and discussing how to meet them.
Participant experience
A brief experience in biologics manufacturing and characterization could be helpful to enrich discussion and exchange during our training.
The workshop is intended to be a ‘two-way’ learning and discussion experience; questions and subsequent discussion are welcome at any time during the workshop.
The presentation will be followed by questions and answers throughout the training.
Docente/i
Fernanda Manhães
Fernanda has a PharmD degree, a Master in Health Economics and Pharmacoeconomics and a course of Leadership in Innovation from the Massachusetts Institute of Technology (MIT). With her more than 10 years of experience in Regulatory Affairs, she has assisted many pharmaceutical companies in all stages of growth, from start-ups to established multinationals, with the global regulatory strategy to filings in Europe, US and Brazil. Her experience ranges from clinical trials to marketing authorizations and post-authorizations including chemicals, biologics, and medical devices/combination products.
Online Training – 2 modules
Module 1 | 14 May 2025 from 02:30 pm to 05:30 pm CEST
Module 2 | 15 May 2025 from 02:30 pm to 05:30 pm CEST
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 680,00* (until 23 April 2025)
Ordinary: € 870,00*
Freelance – Academy – Public Administration**: € 495,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Registrati
Roberta Alberti
Events & Training Manager
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.