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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
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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
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personal data

Thank you! Your submission has been received!
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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
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BIOTECH LAW & POLICY

Master ADC Manufacturing Compliance with Wisdom's Expert Training

Training Schedule  (08th, 09th & 10th May, 2024)
‍
(08th May, 2024)
14:30 - 18.40 PM UK time

(09th May, 2024)
14:30 - 18.40 PM UK time

(10th May, 2024)
14:30 - 18.40 PM UK time


Online

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

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Register

Andrea Stazi,

‍Full Professor of Comparative Biotechnology Law at San Raffaele University of
Rome; Visiting Professor inBiotechnology Law and Academic Fellow of the Centre
for Technology, Robotics, Artificial Intelligence andthe Law at National
University of Singapore, Regulatory Affairs Lead South EU Google and Public
Policy Lead South EU YouTube.

Biotech Law & Policy

Training Schedule  (08th, 09th & 10th May, 2024)

14:30 - 18.40 UK TIME


ABOUT:

The training will deal with the legal, policy, economic, social and ethical
issues arising from the application of biotechnology techniques and the use of
their methods and products in various sectors, such as medical, agricultural,
etc. In an international and comparative perspective, after introducing to the
fundamentals of biology, genetics, intellectual property and patent law,
different regulatory systems for research and development using controversial
biotechnology techniques, including human genetic modification and cloning,
GMOs, CRISPR, etc., will be analyzed.

The multidisciplinary approach adopted will take into account aspects like
ethics of interventions on human life, access to genetic resources,
sustainability, biodiversity and foods sovereignty. Specific issues that will be
analysed include patentability of biological materials, gene sequences, stem
cells, plants, animals, humans, medical treatments, and the most recent issue of
the role of intellectual property in the COVID-19 pandemic. According to an
active learning model based on the active participation of the students,
specific discussions will take place regarding the latest developments of
bioinformatics and computational experimentation, especially through the most
recent advances in big data analysis, machine learning and artificial
intelligence (including generative AI).


TRAINER PROFILE:

Andrea Stazi

Full Professor of Comparative Biotechnology Law at San Raffaele University of
Rome; Visiting Professor inBiotechnology Law and Academic Fellow of the Centre
for Technology, Robotics, Artificial Intelligence andthe Law at National
University of Singapore, Regulatory Affairs Lead South EU Google and Public
Policy Lead South EU YouTube.‍


TRAINING STRUCTURE

1. INTRODUCTION TO BIOTECHNOLOGY: HISTORY, DEFINITIONS AND TECHNIQUES

1.1. The Biotech Revolution - 1.2. Definitions - 1.3. History - 1.4. Techniques

2. BIOTECHNOLOGY ECONOMY AND SUSTAINABILITY

2.1. Biotech Economy - 2.2. Industrial Biotechnology - 2.3. High Volume Sectors
- 2.4. High Value

Sectors - 2.5. Biotech and Sustainability: GMOs

3. INTERNATIONAL LAW AND BIOTECH POLICY

3.1. Biotechnology and the Law - 3.2. Biotechnology in International Law - 3.3.
Biotech Policy:

Principles and Approaches

4. BIOTECH INVENTIONS AND PATENTABILITY

4.1. Patent System and Biotechnology - 4.2. Patentability of Biotech Inventions
- 4.3. Limits of

Patentability - 4.4. Patentability of Life Forms

5. BIOTECH, BIOETHICS AND BIOLAW

5.1. Biotech and Morality - 5.2. Bioethics and Biolaw - 5.3. Biotechnology and
Human Life

6. BIOINFORMATICS, BIG DATA AND AI

6.1. Bioinformatics - 6.2. Biotech and Big Data - 6.3. Biotech and Artificial
Intelligence

‍

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

View agenda
Register


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

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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