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ATMP
August 8, 2022
August 8, 2022
Designing a Safety and Risk Management System for Cellular Therapies
December 8, 2021
December 8, 2021
Role of CAR-T therapies in haematological malignancies
March 9, 2021
March 9, 2021
Classification of cellular therapy and gene therapy (CGT) products: How regulators are working with industry
March 8, 2021
March 8, 2021
End-to-end pharmacovigilance support for a UK-based pharmaceutical company
APCER’s Pharmacovigilance (PV) team supported a client’s expansion into new markets by setting up a
…
March 8, 2021
March 8, 2021
Setting up Agile PV operations for a US based Pharma company
APCER’s Pharmacovigilance (PV) team helped a biotech pharmaceutical company with set up, training and database
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March 8, 2021
March 8, 2021
Enabling global expansion by establishing an integrated PV system
APCER helped a global pharmaceutical company in establishing a collaborative global pharmacovigilance (PV) governance model;
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March 8, 2021
March 8, 2021
Active remediation measures help mitigate major safety findings
APCER Life Sciences supported one of the biopharma companies in assessing the effectiveness and setting
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March 8, 2021
March 8, 2021
Inspection Readiness: Supporting the pharma company in ensuring regulatory compliance with highest standards
Read how our Quality Assurance team helped a pharma company successfully host the USFDA inspection
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March 8, 2021
March 8, 2021
Streamlining lifecycle management through proficient eCTD submission roadmap
APCER’s Pharmacovigilance (PV) team provided PV services right from set up, training and database usage.
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March 8, 2021
March 8, 2021
GCP Audits in EU requiring local language competency for a biopharma company
We helped a biopharma company to set up end-to-end Quality Management System (QMS) and successfully
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March 8, 2021
March 8, 2021
Significance of Medical Monitoring in smooth progression of clinical trials
APCER Life Sciences helped develop the strategy and provided medical monitoring services that accelerated the
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March 8, 2021
March 8, 2021
Bridging the gaps and inconsistencies within CT program through an expert overlay of medical monitors
Our medical monitoring team with experience and expertise in early clinical development stages provided oversight
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January 12, 2021
January 12, 2021
Importance of Engaging a Safety Partner Early in the Drug Life Cycle
Ms. Jeanne Schow, Vice President & US Head of Business Development talks the key benefits
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January 10, 2021
January 10, 2021
Risk minimisation measures: Tracking and effectiveness assessment
January 6, 2021
January 6, 2021
RMP Team Collaboration Across Functions
January 6, 2021
January 6, 2021
aRMM Implementation Strategy
January 6, 2021
January 6, 2021
Identification of risks and determination of aRRM requirement
December 11, 2020
December 11, 2020
Advanced Therapy Medicinal Products – The Next Therapeutic Revolution
Dr. Vineet Kacker, Managing Director & Global Technical Head talks about the how Advanced Therapy
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September 11, 2020
September 11, 2020
Personalized Therapy with Advanced Therapy Medicinal Products: A Paradigm Shift
June 1, 2020
June 1, 2020
Role of Cellular Therapies in COVID-19 Management
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