www.wisdomevents.net Open in urlscan Pro
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Submitted URL:
https://inviteapp.wsdevents.com/l/7OBn5WQ4v2cSQLB3EKtmTA/SqxAiZUZWX9nYXev8RCcvg/763vYK892XJ9ODL3c5mNmf763C4w
Effective URL:
https://www.wisdomevents.net/pharma
Submission: On January 17 via manual (January 17th 2024, 11:05:56 pm UTC) from US — Scanned from NL

Form analysis
3 forms found in the DOM

Name: wf-form-Contact-us-Form-Pharma — GET

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</form>

Name: wf-form-Agenda-Form-Pharma — GET

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Name: wf-form-Sponsorship-Form — GET

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Text Content

GET IN TOUCH

Enter your First nameEnter your Last nameEnter your Job TitleEnter your Company
NameEnter your CountryEnter your emailEnter your Phone Number
By clicking the "Submit" button, you confirm your consent to the processing of
personal data
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.




AGENDA

You are just one click away!
Confirm your details and you will see the Agenda in the next window.First and
Last nameCompany NameEmail AddressPhone Number
By clicking the "Submit" button, you confirm your consent to the processing of
personal data

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.



SPONSORSHIP

Enter your First nameEnter your Last nameEnter your Job TitleEnter your Company
NameEnter your CountryEnter your emailEnter your Phone NumberChoose
sponsorshipPlatinumGoldSilverBronzeAwards ceremonyNetworking IdentityBusiness
programCocktail partyDigital marketingHost
By clicking the "Submit" button, you confirm your consent to the processing of
personal data
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.


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REGULATION, QUALITY & COMPLIANCE IN ADC MANUFACTURING - MASTER CLASS

Master ADC Manufacturing Compliance with Wisdom's Expert Training

Training Schedule  (26th & 27th March, 2024)
‍
(26th March, 2024)
13:00 - 17:15 PM UK time
09:00 - 13:15 PM New York time

(27th March, 2024)
13:00 - 17:15 PM UK time
09:00 - 13:15 PM New York time

Online

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Join visionary speakers from leading organisations for crucial insights and
expert opinions.

View agenda
Register

Dr. Len Pattenden, Managing Director, CMC Biopharma Ltd

Regulation, Quality & Compliance in ADC Manufacturing

Training Schedule (26th & 27th March, 2024)

13:00 - 17:15 PM UK time
09:00 - 13:15 PM New York time


ABOUT:

The manufacturing of Antibody-Drug Conjugates (ADCs) is intrinsically complex
and a strong chemistry, manufacturing and control (CMC) strategy is vital due to
the complex nature of these therapeutics and history of failures at both early
and late stages. This training encompasses a comprehensive understanding of the
primary technical and regulatory (FDA and EMA) challenges; focusing on the
specific requirements for ADCs, which combine the targeting capabilities of
antibodies with the cell-killing or effector capabilities of payload drugs. The
overall operational excellence and Quality approach is highlighted as well as
the critical points for control to ensure the consistency, purity and stability
of ADCs, given their high potency and specific targeting mechanisms. Training
also covers good manufacturing practices (GMP) procedures - especially tech
transfer, documentation and facility controls. The latter being crucial for
minimizing cross-contamination risks. This training combines theoretical
knowledge with workshopping for deeper understanding to prepare professionals
for the unique challenges in ADC manufacturing



WHO SHOULD ATTEND?

This training is essential for professionals from leading pharma manufacturing
companies, including:


Quality
Quality assurance
Quality Control
CMC Managers/ Heads
Compliance
Regulatory Affairs
QA/QC Managers
Analytical Scientists
Development Scientists
Manufacturing
Process Development
Upstream/Downstream
R&D Scientists
Operations
& VC/investors in Biologics



TRAINER PROFILE:


Dr. Len Pattenden, Managing Director, CMC Biopharma Ltd

Len has over 30 years of experience in both industry and academia. Len has been
a company founder, COO and GMP site head/license holder, overseeing biopharma
development and manufacture as well as outsourced CDMO activities. Len has
undertaken development and manufacturing of 18 new biological entities,
including first-in-man/first-in-class cell and gene therapies, viral vectors,
biologics, and monoclonal antibodies. Len’s regulatory and licensing experience
covers the MHRA, EMA and FDA. Len works as a CMC consultant for small and large
pharmaceutical companies. He is a member of a Regulatory working group, the ISPE
and BIA

Key Outcomes:


 * An understanding of the mechanism of action and pharmacology important to
   success of ADCs
 * An understanding of the key steps and technical challenges of GMP ADC
   manufacture that create market-approval delays
 * An insight into Regulatory drivers and how this impacts assessment of filings
 * Operational excellence and Quality by Design (QbD) principles applied to ADCs
 * Change management and tech transfer for ADCs
 * Critical points for control to establish good CMC-compliant regulatory
   practices for ADCs
   

Training Schedule (26th & 27th March, 2024)

14:00 - 18:15 PM CET time
13:00 - 17:15 PM UK time
09:00 - 13:15 PM New York time



METHODOLOGY:

The participants will acquire knowledge through interactive sessions that are
structured like lectures, allocating ample time for various activities, Q&A
sessions, and discussions. Additionally, the training emphasises practical
learning, incorporating case studies, breakout sessions, interactive polls, and
examples from real-case scenarios.


ADDITIONAL FEATURES:

 * Online participants zone – a single source for all training materials as well
   as pre and post training communications
 * Access to the recorded sessions for 7 days


ABOUT THIS EVENT

The manufacturing of Antibody-Drug Conjugates (ADCs) is intrinsically complex,
and a robust Chemistry, Manufacturing, and Control (CMC) strategy is vital due
to the complex nature of these therapeutics and the history of failures at both
early and late stages.

This training encompasses a comprehensive understanding of the primary technical
and regulatory challenges (FDA and EMA), focusing on the specific requirements
for ADCs. ADCs combine the targeting capabilities of antibodies with the
cell-killing or effector capabilities of payload drugs. The overall operational
excellence and Quality approach are highlighted, along with critical control
points to ensure the consistency, purity, and stability of ADCs, given their
high potency and specific targeting mechanisms. The training also covers good
manufacturing practices (GMP) procedures, especially tech transfer,
documentation, and facility controls, which are crucial for minimizing
cross-contamination risks. This training combines theoretical knowledge with
workshopping for a deeper understanding, preparing professionals for the unique
challenges in ADC manufacturing.





OUR EVENTS

Slide 2 of 3.







We are a high-profile corporate events organiser for professionals from
commercial, government, and research segments. We deliver summits, conferences,
exhibitions, and business meetings of exceptional quality, encompassing diverse
industry verticals such as pharma, energy, maritime, agro, technology,
healthcare, marketing, and more.
Visit our website: wisdom.events

Phone number

+ 44 208 157 7002
Contact us

E-mail

info@wisdom.events