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Latest Conference Articles
The Impact of AI on Pharma
October 15th 2023
CPHI’s Annual Report predicts huge impact of AI on drug development and manufacturing.
Global Cell Therapy Requirements Need Thorough Understanding
October 13th 2023
Humberto Vega, PhD, Executive Director, Bristol Myers Squibb, discusses the requirements needed to be successful in global cell therapy as a part of his session, "Successfully Navigating Global Cell Therapy Requirements."
The Challenges of the Journey from Clinical to Commercial Cell Therapies
October 12th 2023
Humberto Vega, PhD, Executive Director, Bristol Myers Squibb, discusses the journey from clinical to commercial cell therapies as a part of his session, "Successfully Navigating Global Cell Therapy Requirements."
Highlighting CAR-T as an Important Modality (PDA/FDA Joint Regulatory Conference 2023)
October 11th 2023
Bassem Gayed, PhD, Senior Technical Director of CAR-T Process Engineering, Manufacturing Science & Technology at Bristol Myers Squibb, discusses the importance of CAR-T as a modality.
CAR-T and Process Validation (PDA/FDA Joint Regulatory Conference 2023)
October 10th 2023
Bassem Gayed, PhD, Senior Technical Director of CAR-T Process Engineering, Manufacturing Science & Technology at Bristol Myers Squibb, discusses the connection of process validation and CAR-T processes.
Improving Facilities in an Efficient Manner (PDA/FDA Joint Regulatory Conference 2023)
September 21st 2023
Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses how to upgrade facilities in an efficient manner and other highlights from his presentation.
Continuous Manufacturing is Here to Stay (PDA/FDA Joint Regulatory Conference 2023)
September 20th 2023
Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future.
ICH Q9 R1 Hits Major Milestones for the Pharmaceutical Industry
September 20th 2023
As for the topic of subjectivity, Viehmann said how high levels of subjectivity in risk assessments and in QRM are problematic and are not aligned with the 1st QRM principle of Q9.
Highlights of ICH Q13 Session (PDA/FDA Joint Regulatory Conference 2023)
September 20th 2023
Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the highlights of her ICH Q13 session that she wants others to be aware of.
Staying Compliant in 2023
September 20th 2023
Leaders at CDER and CBER give update on organizational changes at FDA.