On the 14th of December, we conducted the webinar “Investigational Medicinal Products in the new era of Clinical Trial Regulation 536/14: How to manage them?” with Luciano Gambini, GMP Consultant.
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About the Webinar
From 31st January 2023, all European clinical trials shall be submitted through a centralized CTIS and the lifecycle of the IMPs shall be managed throughout the new regulatory frame following the implementation of the CTR536/14. This is a big change: any step in handling IMP is affected, even if not deeply by this new situation.
This webinar is aimed to highlight the best way to adequately update the quality system for the IMPs, particularly for the aspects involving both GMP and GCP regulatory sides as well as drawing attention to the steps (packaging and labeling) characterizing the IMP versus commercial products.
What will you learn watching the webinar?
During our free webinar, the main differences between the regulatory frame under CTD 2001/20 and CTR 536/14 will be highlighted, allowing an internal gap analysis to identify the process/procedure to be updated to be compliant with the new regulatory frame.
Language
English
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Speaker
Luciano Gambini
GMP Consultant
Luciano Gambini has spent most of his professional career in R&D taking care of the different quality aspects of the Investigational Medicinal Products (first in analytical development, then in the quality assurance department of Farmitalia Carlo Erba, Pharmacia&Upjohn, Pharmacia, NMS).
He began his professional career as an analyst in the Physical Chemical Lab of Farmitalia Carlo Erba and moved, after this experience, to the Pharmaceutical Controls Lab of the same Company, in charge of life cycle management of anti-cancer drug formulations, playing an important role in the invention of two novel patented formulations.
Since 1992, when he became the head of the Validation Section, Luciano Gambini has taken care of the validation of the facilities, utilities, and equipment of Pharmaceutical Development (Pharmacia & Upjohn) in Nerviano. After this experience, in 2000 he took the role of manager of the Quality Assurance department, involved in the preparation of the investigational medicinal products (in Pharmaceutical Sciences and then in Global R&D QA) of Pharmacia R&D Italy. In this position, he played a part in the development of Corporate Quality Standards for IMPs in compliance with the new regulations (Annex 13 and EU Directive 2001/20).
He terminated his professional career as responsible for the Quality Assurance Group in the Business Unit of Pharmaceutical Sciences of Nerviano Medical Sciences, a spin-off company from Pfizer.
He is the author of several presentations on IMP-related topics at European conferences and seminars as well as articles in Italian scientific magazines.
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About Arithmos
We are Business and Technology experts in the Life Science industry.
We help companies to gain the best business value through technology-enabled solutions. With our business units seQure and The CQA Company, we provide Quality Compliance and Consulting services.
We deliver solutions and services for:
- Pharmacovigilance and Safety
- Regulated Document Management
- Reporting & Analytics
- eClinical
- Quality Management
- Computer System Validation
- Regulatory Affairs
- Cloud Services
- IT Services
Our industry-leading experts combine the knowledge of processes and technologies to implement your digital strategy, enable rapidly scale-up along with fulfilling oversight, governance, and compliance requirements.
We support your:
- Digital Transformation
- Business Process Re-engineering
- System Integration
- Data-Driven Management
