Learning outcomes
Training description
This MasterClass will provide a deep and detailed instruction on Chemistry, Manufacturing and Controls (CMC) requirements and review processes for clinical trial, registration and postapproval drug applications. Attendees will also have a solid but comprehensive overview of all relevant regulatory, technical and quality elements, implementation and documentation of the required CMC analytical and stability knowledge for biotechnology products, including biosimilar products. Practical examples will be provided as illustration and proper time will be allowed for discussion designs and outcomes.
By the end of the MasterClass, the participants will understand:
• Process development strategies
• Analytical and Formulation development
• GMP manufacture
• Process analytical Technology
• Guidelines and Regulatory pathways for New Biological entities and Biosimilars
Training schedule
Day one
08:30 Registration & Networking with Welcome Coffee
08:45 Session 1:
Introduction to Biologics10:00 Session 2 Part 1:
Life cycle of Biotherapeutics development from Discovery to Market approval11:00 Tea, Coffee, Networking
11:20 Session 2 , Part 2
12:00 Session 3 Part 1:
Process development strategies13:00 Luncheon & Networking
14:00 Session 3, part 2
15:00 Session 4:
Analytical and Formulation development16:15 Tea, Coffee, Networking
16:35 Session 5: GMP manufacture
17:50 End of day 1
Day two
08:30 Tea, Coffee, Networking
08:50 Recap from Day 1
09:00 Session 6 Part 1:
Control strategy life cycle10:00 Session 6, Part 2
10:45 Tea, Coffee, Networking
11:00 Session 7: Guidelines and Regulatory landscape
12:30 Luncheon & Networking
13:15 Case study I: New biological entity
14:00 Case study II: Biosimilar
14:30 Closing Remarks, Recap
15:00 End of day 2
15:15 Farewell Tea, Coffee and Networking
Training Program
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Get to know the Expert Trainer
Dr Andreu Soldevila is the founder and CEO of Leanbio and Co-founder and CEO of Syna therapeutics, companies dedicated to Biotherapeutics development, manufacture and commercialization. Leanbio is a CDMO founded in 2014 dedicated to both New Biologic entities and Biosimilars, whereas Syna Therapeutics is a Biotherapeutics Developer, founded in 2017 and currently has two products in the pipeline.
Andreu developed as a professional in the field of Biotechnology for the last 20 years, moving from initial applied research to CMC regulatory activities, holding Bioanalysis Head of the Department at a multinational company, Head of R&D in a CMO and current CEO positions.
Dr. Soldevila was responsible for a variety of technological achievements related to new microbial and mammalian expression Systems and platform for multiplex absolute quantitation of proteins by LC-MS/MS bottom-up approach at picomolar levels with proven capacity to be applied at discovery, development and manufacture of recombinant proteins and for (non)-clinical trials. In the last 10 years participated in numerous biotherapeutics projects, including 6 Biosimilar products, one of them already submitted for Market authorization license.
Who should attend?
• QC release and stability analysts
• Stability program managers
• Product scientists and test method technical experts (R&D and QC)
• Process analytical chemists and process development scientists
• Quality assurance specialists
• GMP compliance auditors
• Regulatory affairs CMC authors or reviewers
• Analytical and stability laboratory managers (R&D through GMP)
• Project managers with CMC responsibilities
• Business managers with CMC responsibilities
• Key staff from biotech academic incubators and small start-ups
• Contract testing labs
• Chemistry, Manufacturing & Controls (CMC) regulatory
• biopharmaceuticals, biosimilars
• or other biologics
• Executive and operational managers of pharmaceutical companies, packaging operations
• Engineering staff
• Quality
• Product Development Materials handling/management
• Product Information Operations
• Licensing
• Biotech companies HTAs
• Governments
• Engineering Lean production
• Procurement
• Purchase/Facilities Manufacturing Technology
• Supply chain and logistics
• Payers
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FAQ
The client has the right to cancel his/her registration in the event.
There is a 50% liability on all conference registrations once made, whether the booking was made through our website or via e–mail/ telephone/ fax.
If the client cancels with more than 8 weeks’s advance notice, GLC shall be entitled to an amount equivalent to 50% of the conference fee and 16 EUR administration charge. In case the client has already made his/her payment, this will be deducted from the conference fee GLC has already received and the remainder will be refunded. If no conference fee has been received prior to the cancellation request, GLC will issue an invoice for the cancellation fee (the amount equivalent to 50% of the conference fee and 16 EUR administration charge), which the client must pay immediately upon receipt. No refunds are available for cancellations received with 8 week’s (or less) advance notice or in case the client fails to attend the conference. In these cases, the full amount of the conference fee must be paid.
- Get the timing right.
Many people are afraid to request for training budget, because they can’t seem to find the “perfect time” to do it. Well, there’s no perfect time to ask for it, but there are definitely some moments that are better than others. For instance, if your boss is about to take a two week vacation, he/she might be in a good mood. If he/she just lost a major account, may not be wise at that juncture. - Make a case for yourself
When you ask for budget, you should be prepared with specific details and explanations about what is in it for the company and you’re superior. If you go into a meeting and just say, “I want to get budget for a conference,” it’s likely that your request won’t be taken seriously. If you want to plan ahead, then you should be prepared to explain the following points:
1. Start by stating your accomplishments
2. Show that you’re ready for more responsibility and eager to learn
3. Describe:
a) How this event will increase your productivity?
b) How you will need less supervision
c) How you can bring back the knowledge to the company
4. Follow up