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Good Clinical Practice with ATMP Clinical Trials USA

Training Course Description

Revolutionizing Treatment: Navigating the Complexities of Cell and Gene Therapy in Advanced Therapy Medicinal Products (ATMPs) Clinical Trials

In the realm of modern medicine, drug development, especially of Advanced Therapy
Medicinal Products (ATMPs), has sparked a paradigm shift, offering unprecedented potential
in treating previously incurable diseases. Among these groundbreaking therapies, cell and
gene therapy stand at the forefront, promising targeted solutions at the molecular level.
We will delve into general good clinical aspects as well as into the intricate landscape of cell
and gene therapy clinical trials. Exploring the diverse spectrum of Good Clinical Practice,
including sponsor and investigator responsibilities, risk-based approaches, and quality by design, we will also address ATMP aspects.
Navigating the complex regulatory landscape demands a comprehensive understanding of
guidelines and compliance frameworks set forth by regulatory authorities. We will elucidate
the critical regulatory nuances, ensuring clarity on compliance requirements essential for
successful clinical trial execution.
Furthermore, operational considerations hold pivotal significance in the seamless conduct of
ATMP clinical trials. Deliberating on key operational elements, such as patient selection
criteria, IMP logistical intricacies, and long-term follow-ups, we will illuminate best practices
essential for the efficient management of cell and gene therapy clinical trials.

 

Why Attend this Training?

Embrace the future of clinical research in advanced therapies!

Join our training to gain a competitive edge in navigating the intricate landscape of ATMP clinical trials. Elevate your expertise, stay at the forefront of industry advancements, and unlock unparalleled opportunities for professional growth. This training is your gateway to mastering the nuances of GCP in the dynamic realm of cell and gene therapy, empowering you to contribute significantly to groundbreaking medical advancements.

By attending this course, you will:

  • In-Depth Understanding: Develop a profound comprehension of general Good Clinical Practice (GCP) principles, with a specialized focus on ATMP clinical trials, including cell and
    gene therapies.
  • Sponsor and Investigator Responsibilities: Gain insights into the specific responsibilities of sponsors and investigators in the context of ATMPs, ensuring a holistic understanding of
    roles and obligations.
  • Risk-Based Approaches: Acquire knowledge on implementing risk-based approaches to enhance the quality and efficiency of ATMP clinical trials.
  • Quality by Design: Explore the concept of Quality by Design (QbD) in the context of ATMPs, understanding its significance in ensuring the success of clinical trials.
  • Regulatory Compliance: Navigate the complex regulatory landscape with confidence, mastering critical nuances and compliance requirements set by regulatory authorities for ATMP clinical trials
  • Operational Best Practices: Deliberate on key operational elements, such as patient selection criteria, Investigational Medicinal Product (IMP) logistical intricacies, and long-term
    follow-ups, to efficiently manage cell and gene therapy clinical trials.
  • Career Advancement: Position yourself as a leader in the evolving field of ATMPs, enhancing your career prospects and contributing meaningfully to groundbreaking
    advancements in medical research.
 
 
 

 

Who should attend?

 

This course is relevant for:

This training is tailored for professionals and individuals engaged in or aspiring to be part of the dynamic landscape of Advanced Therapy Medicinal Products (ATMP) clinical trials. The target audience includes, but is not limited to:

  • Clinical Research Professionals: Clinical trial coordinators, monitors, and
    managers seeking specialized knowledge in the unique GCP challenges and
    interested in ATMP clinical trials.
  • Regulatory Affairs Specialists: Professionals involved in navigating the regulatory landscape, ensuring compliance, and staying abreast of evolving GCP guidelines, incl. the realm of ATMPs
  • Investigators and Site Staff: Investigators, site coordinators, and staff involved in executing clinical trials, particularly those dealing with cell and gene therapies.
  • Pharmaceutical and Biotech Professionals: Individuals working in pharmaceutical
    and biotech companies involved in the drug development and execution of clinical trials, also with ATMPs.
  • Quality Assurance and Compliance Personnel: Professionals responsible for
    maintaining quality standards and ensuring compliance throughout the clinical trial lifecycle.
  • Healthcare and Medical Professionals: Physicians, nurses, and other healthcare
    professionals interested in understanding and contributing to the advancement of ATMPs
  • Industry Consultants and Advisors: Professionals providing consultancy or advisory services in the field of ATMP clinical trials, aiming to enhance their expertise.

This training is designed to cater to a diverse audience involved in different facets of clinical research, ensuring that each participant gains valuable insights and skills relevant to their specific roles within the ATMP landscape.

 
 

About the trainers

Jessica Cordes – Consultant & Trainer in Clinical Research || Oncology & Gene and Cell Therapy

Jessica Cordes

Throughout her 15-year journey in clinical drug development, she has been captivated by the
human stories behind the science, particularly in addressing the critical needs of patients
battling blood cancer and solid tumors.
In her leadership roles within Clinical Operations over the past 6 years, she has cherished the collaborative spirit that fueled pursuit of innovative cell and gene therapies.
Witnessing the convergence of expertise and empathy, they didn’t just develop drugs;
they crafted narratives of hope and progress with truly inspiring and cohesive teams.
This distinguished trainer has been at the forefront of blending scientific acumen with compassionate care, leading teams that transform innovative research into tangible treatments. Their journey is marked not only
by the milestones in drug development but also by the stories of lives touched and improved through their dedicated efforts.

GCP with ATMP Clinical Trials Event USA

GCP with ATMP Clinical Trials Event USA

1599 (1749 $)

Livestreaming Zoom _____ ✔️ Interactive Lectures _______✔️ Get 2 seats for the price of 1__ ✔️ Free Recording one month access _____ ✔️

SECURE YOUR SEAT

REGISTER 2 FOR 1

GCP with ATMP Clinical Trials Event USA
8:45 am - 9:00 am Online

Connecting to training course

9:00 am - 9:15 am Online

Introduction

9:15 am - 10:00 am Online

Ethical Foundations

• Declaration of Helsinki • Declaration of Taipeh

10:00 am - 10:30 am Online

Legal Foundations

• EudraLex – Volume 10 • Implementation of international standards into the national law • EU Clinical Trials Regulation (536/2014)

10:30 am - 10:40 am Online

Coffee Break

10:40 am - 12:25 pm Online

Legal Foundations

• ICH E6(R2) - An International Standard • ICH E6 (R3) - Changes at a Glance • ICH E8 (R1) - General Considerations for Clinical Studies • ATMP Guidelines

12:25 pm - 12:30 pm Online

Break

12:30 pm - 1:00 pm Online

Trial Master File

• Documentation • Essential documents • Archiving • Publication

8:45 am - 9:00 am Online

Connecting to training course

9:00 am - 9:10 am Online

Questions & Feedback

9:10 am - 11:00 am Online

Sponsor Responsibilities

• Sponsor Responsibilities • Investigator Selection • Risk-based Quality Management • Quality Assurance and Quality Control, Monitoring • Oversight of Service Providers • Data Governance – from Data Collection to Data Analysis • Validation of Computerised Systems • Investigational Medicinal Products • Safety Assessment and Reporting • Insurance • Reporting Obligations of Non-Compliance

11:00 am - 11:10 am Online

Coffee break

11:10 am - 12:10 pm Online

Investigator Responsibilities

• Patient Information and Informed Consent • Qualification of the Site Team • Source Data and Documentation • Oversight as Responsibility • Handling of Investigational Medicinal Product • Patient Safety • Protocol Compliance

12:10 pm - 12:15 pm Online

Break

12:15 pm - 1:00 pm Online

GCP audits and inspections

• Impact of Audits and Inspections • Findings and the consequences for Sponsor and Investigator • Typical Findings

  • Date : September 18, 2024 - September 19, 2024
  • Time : 9:00 am - 1:00 pm (UTC-5)
  • Reg. Deadline : September 18, 2024 8:00 am
  • Venue : North America

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