ATMP

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

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
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;
March 8, 2021

Active remediation measures help mitigate major safety findings

March 8, 2021

Inspection Readiness: Supporting the pharma company in ensuring regulatory compliance with highest standards

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.
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
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
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
February 18, 2021

Classification of cellular therapy and gene therapy (CGT) products: How regulators are working with industry

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
January 10, 2021

Risk minimisation measures: Tracking and effectiveness assessment

January 6, 2021

RMP Team Collaboration Across Functions

January 6, 2021

aRMM Implementation Strategy

January 6, 2021

Identification of risks and determination of aRRM requirement

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
September 11, 2020

Personalized Therapy with Advanced Therapy Medicinal Products: A Paradigm Shift

June 1, 2020

Role of Cellular Therapies in COVID-19 Management