Introduzione
Advanced therapy medicinal products (ATMPs) are currently undergoing a boom. Several products including viral, non-viral and cell-based products have forged a path to market. In their wake, academics and clinicians continue to lead innovation and unlock the clinical potential of new approaches and technologies, whereas increased industry interest is stimulating investment and industrialization of the processes that lead to commercialization.
This online training course is designed to give a broad scientific and regulatory overview of the current state of the art and challenges facing ATMP development. It will follow the life cycle of an ATMP from concept to clinic and commercialization. and it will take into consideration global regulatory requirements and the often-challenging regulatory problems that ATMPs face.
MODULE 1 (Lecturer: Giovanni Migliaccio)
Introduction to ATMPs and drug development
- Overview of small molecule drug development vs complex biological drug development
- EU regulatory framework for ATMPs
- US regulatory framework for ATMPs
Getting on the right track: early stage regulatory procedures for ATMP development
- ATMP classification
- Early stage regulatory procedures brief overview Orphan drug designation (ODD), Paediatric investigation plans (PIPs) and Pediatric study plans (PSPs)., Innovation meetings / scientific advice / protocol assistance / pre-IND meetings, Risk-based assessment and PRIME
MODULE 2 (Lecturer: Giovanni Migliaccio)
Chemistry, manufacturing and controls (CMC) for ATMPs
- Introduction to GMP and GMP guidelines
- Gene therapy manufacture main concepts
- Cell-based therapy manufacture main concepts
- QP release and import/export
Nonclinical issues
- Overview of nonclinical studies and timing
- Certification of CMC and/or nonclinical data for ATMPs and SMEs
MODULE 3 (Lecturer: Giulia Detela)
Clinical issues
- CTAs and INDs
- Core documents
- GCP for ATMPs
- Clinical trials design considerations
- Long-term follow up requirements
- GMO applications, site licenses
Marketing authorization procedures
- EU centralised procedure and US biologics license application (BLA)
- Accelerated assessments, expedited programs and conditional approval
- Hospital exemption and compassionate use
- Pharmacovigilance and risk management plans (RMPs)
- Regulatory Affairs Manager, Officer and Specialist
Development Pharmacist
Project Manager
working for pharmaceutical company, Biotech, spin-offs and CROs.
It is also addressed to Researchers and academics in the ATMP field.
Participant experience
Participants need to have a basic understanding of regulatory procedures and/or a basic knowledge of ATMP biology.
This limited enrolment online training course is intended to be a virtual class where various expert will guide you into the topics through real world case studies and examples and answering your questions.
Docente/i
Giovanni Migliaccio
Giovanni Migliaccio is the Scientific Director of the Centro Valutazioni Biologiche e Farmacologiche, (CVBF Pavia, IT) and a Senior Advisor for the European Translational Medicine Research Infrastructure (EATRIS, Amsterdam NL).
He obtained a PhD in Biological science in 1977 at the University of Naples (Italy). His interest in science developed around stem cell proliferation and differentiation mechanisms. He spent two years as Post Doc at the University of Washington (Seattle, WA) and 5 years as Associate Scientist at the New York Blood Center (New York, NY). He continued his studies at the Istituto Superiore di Sanità (ISS) in Rome resulting in more than 150 scientific publications over the years.
He is involved in the regulatory aspects of using cultured cells as part of human therapies and acts as an expert for the Italian government in the area of Cell and Gene Therapies. He is also an expert for these products for the European Medicines Agency (EMA). He was also the Chair of the CTP group at the European Department for Quality of Medicines (EDQM) from 2010 to 2018.
Giulia Detela
Dr Giulia Detela is a customer-focused, global Regulatory Affairs Lead within Regulatory Science at PPD, now part of Thermo Fisher Scientific.
Her experience in managing multinational clinical trials spans from pre-start up phases through maintenance and end stages for phase I, II and III clinical trials across global jurisdictions.
Dr Detela supports developers of cell and gene therapy products to interact with EU national Competent Authorities, the European Medicines Agency and with EU pre-authorisation procedures, including: ATMP Classification, Orphan Designation, Scientific Advice and Protocol Assistance, PRIME and Paediatric Procedures.
Before joining PPD, Dr Detela worked as cell and gene therapy Process Development Scientist and covered quality and regulatory roles for the generation of automated systems for the manufacturing of cell-based products.
Dr Detela has over 11 years of experience within the pharmaceutical sector (including research and regulatory roles). She holds a BSc in Cell and Molecular Biology and a MSc in Functional Genomics from the University of Trieste, Italy, as well as a PhD in Regenerative Medicine-Biochemical Engineering from University College London in the United Kingdom.
Online Training – 3 modules
MODULE 1 | 03 May 2022 from 2.00 pm to 5.00 pm CEST
MODULE 2 | 05 May 2022 from 2.00 pm to 5.00 pm CEST
MODULE 3 | 10 May 2022 from 2.00 pm to 5.00 pm CEST
After the registration, you will receive all details about the connection.
The course admits maximum 12 attendees.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 1.100,00* (until 5 April 2022)
Ordinary: € 1.310,00*
Freelance – Academy – Public Administration**: € 660,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Registrati
Versione Stampabile
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.