SUMMARY
ICH and Pharma 4.0: The Implications for Brazil
A 60-minute cross-industry panel of experts will explore how the recently adopted International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines will impact key stakeholders in the manufacturing of pharmaceutical products in Brazil.
Regulatory professionals, pharmaceutical executives, academic researchers, and other interested parties will gain an understanding of how the ICH Guidelines, Pharma 4.0 and Quality by Design principles intersect in the advancement of pharmaceutical manufacturing.
PERSPECTIVES BY
Attendees will learn:
The regulatory implications of ICH adoption for Brazil
How to benefit from the lessons learned from ICH adoption in other countries and regions
How to leveraging digital transformation to put the ICH Guidelines, Pharma 4.0 and Quality by Design (QbD) principles into practice
BIOS
Meet the Speakers
Gustavo Mendes Lima Santos
General Manager, ANVISA, Brazil
Mr. Mendes Lima Santos is General Manager of Medicines and Biological Products at ANVISA, Brazil. He is responsible for the management for drug and biological product registration submission evaluation teams, authorization to conduct clinical trials in Brail, and certification of bioequivalence centers.
Mr. Mendes Lima Santos has been working at ANVISA Brazil since 2003, mostly with bioequivalence/biowaiver studies and clinical trial evaluations. He is a pharmacist with specialization in public health and also holds a Masters degree in Toxicology
Sana Ahmed
Client Service Specialist, CherryCircle Software, UK
Sana Ahmed is the Quality by Design specialist for QbDVision. A young professional with industry experience in both pharmaceutical and cosmetic laboratories, actively participating in raising awareness of the Quality by Design framework as part of the Pharma 4.0 paradigm. Sana works with scientists who have little background in QbD and want to optimise their processes as well as get trained on QbD principles in a practical manner. Since joining the QbDVision team, Sana has created a client-base within the UK and Europe, with a high engagement rate; as well as regularly hosting workshop sessions at the De Montfort University, where she initially obtained her Masters in Quality by Design.
BIOS
Meet the Panelists
Mario Brenga Gianpetro
President, ISPE Brazil Affiliate, Brazil
Mario Brenga Giampetro is a systems Analyst and Business Administrator, he has been in the IT market for over 20 years, with experience in the textile, telecommunications, paper and cellulose industries and engineering companies. He also participated in the creation of the Computerized Systems Validation Guide together with ANVISA professionals published in April 2010. In the last 20 years, he coordinates and carries out Computerized Systems Validation projects with more than 50 validated systems.
Walkiria Schlindwein
Associate Professor in Pharmaceutics De Montfort University, Leicester, UK
Walkiria has over 25 years of experience in academia and is currently Associate Professor in Pharmaceutics at the Leicester School of Pharmacy, De Montfort University. She has led the creation of the first MSc in Pharmaceutical Quality by Design (QbD), in collaboration with partners from the pharmaceutical industry and related supply chain. Her expertise is in the areas of polymer science and technology, advanced techniques for materials’ characterisation, pharmaceutical Quality by Design, continuous processes for early phase product development and manufacture using in-line monitoring process technology and design of experiments.
Line Lundberg
Owner, Lundsberg Consulting, UK
Line Lundsberg, PhD, runs her own consultancy business Lundsberg Consulting Ltd, supporting clients in developing and manufacturing pharmaceutical products and has a role as Global technology Partner within NNE, a global pharma engineering company. She has spent more than 20 years within the pharmaceutical Industry (API & Drug Product Development and Manufacturing). She is specialised in the science and risk-based concept of Pharmaceutical Development and Manufacturing including Quality by Design (QbD), Process Analytical Technology (PAT), Process Validation lifecycle (PV), Good Manufacturing Practise (GMP), Quality Risk Management (QRM), Pharma 4.0 and the related regulatory and compliance aspects.
Line holds a BSc in Mathematics, an MSc in Physics and a PhD in Chemistry on NIR spectroscopy.
Line has worked with innovator and generic companies, both global and national, developing and implementing QbD strategies, QbD programmes, QbD tools, QRM, GMP, PV and Advanced Control Strategies based on Real Time Release Testing (RTRT) including QbD based regulatory submissions of new product applications (MAA, NDA, ANDA). Lately she has been involved in Pharma 4.0 projects.
Line was a co-developer of the QbD MSc course organised by Leicester School of Pharmacy, De Montfort University (DMU), UK, and have recently together with DMU and Wiley contributed to the book ‘Pharmaceutical Quality by Design: A Practical Approach’
Yash Sabharwal
CEO and President, CherryCircle Software, USA
Yash Sabharwal is co-founder, President, and CEO,of CherryCircle Software. He is a successful serial entrepreneur. He has over 20 years of experience in the life science industry.
He was previously co-founder and Chief Operating Officer at Xeris Pharmaceuticals. It was in this role that he crafted the vision for CherryCircle Software.
Yash has a B.S. in Optics from the University of Rochester and a M.S. and Ph.D. in Optical
Sciences from the University of Arizona.