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 Biologics

  • 10:00 Session 2 Part 1:
    Life cycle of Biotherapeutics development from Discovery to Market approval

  • 11:00 Tea, Coffee, Networking

  • 11:20 Session 2 , Part 2

  • 12:00 Session 3 Part 1:
    Process development strategies

  • 13:00 Luncheon & Networking

  • 14:00 Session 3, part 2

  • 15:00 Session 4:
    Analytical and Formulation development

  • 16:15 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 cycle

  • 10:00 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
Dr Andreu SoldevilaCEO, Leanbio

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

You can always register without a name using the TBA [To Be Announced] option. Please indicate TBA instead of the delegate name and 2 weeks prior to the event you are able to send the delegate name/s to booking[at]glceurope.com
While we are not happy to see you cancel your registration, we understand that “life happens” and other obligations come up. Our refund schedule is as follows:
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.
In general no VAT is applied based on the Hungarian VAT law with the exception of individual payment [when you would like to pay from your own budget and not from the company’s budget] and for Hungarian companies where 27% VAT is applicable which is refundable at the end of the company’s fiscal year.
Our hospitality partners usually have options available for parking places, however it can change from event to event. If you would like to receive more information on parking please e-mail our colleague susanna.juhasz[at]glceurope.com.
We provide a conference documentation pack which includes: conference agenda, notes pages and attendee information. Soft copies of some of the presentation are available on USB-flash-drives for each delegate. You may bring your laptop, tablet or other mobile device so you are able to review the presentations while they are being presented. Free Wi-Fi will be provided and outlets will be available for recharging computers, mobile devices and phones. We highly recommend you to bring along your business cards and a desire to learn from some of the industry’s leading experts.
The dress code is business casual. Feel free to leave the suits and ties at home this time. We do suggest you bring a sweater or dress in layers, as the conference room temperature may fluctuate.
Any of our staff members at the event will be delighted to help you. You can contact us for free via WhatsApp or Viber or any time over the phone or via e-mail or post.
  1. 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.
  2. 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
You might find free to attend events which are usually organized by a solution/service provider within the industry. Unlike at free to attend events, on a paid event you will find more diverse industry knowledge rather than presentations related to services or solutions.
In case you cannot attend for both days, you can always attend for just 1 day of the event. In this case we will send you all presentations of the 2 days. The participation fee is 70% of the original investment. In case you would like to attend the event for just 1 day please contact us on booking[at]glceurope.com
In case you are busy on 1 of the days, you certainly can split the 2 day conference with one of your colleague. All you need to do is send us an e-mail to booking[at]glceurope.com
We understand that not all senior-level professionals might be available on the dates. As the event is an annual event, most of the attendees try to postpone their engagements or send a small group from their teams to benefit from the conference.

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