Kirsten Messmer and Charity-Anne Schuller discuss how to maximize regulatory intelligence and offer best practices recommendations.
Regulatory Focus (March 2019)
Rob Petrie comments on some of the keys to the successful use of wearables in clinical trials.
PharmaVOICE (March 2019)
Pat Mann, Kirsten Messmer and Luis Arthur Pelloso provide an overview of new FDA guidances related to oncology drug development.
David Hillman and Clare Ryder outline the pharmacovigilance activities that a prospective marketing authorization holder will need to accomplish in advance of and throughout the application process.
Regulatory Rapporteur (March 2019)
The partnership will focus on data-driven feasibility, patient recruitment and real-world evidence offerings for both global and China-based pharma and biotech companies.
FierceBiotech (February 2019)
Niklas Morton explains how the new collaboration will help pharma companies create better optimized protocols that will prove to be more attractive to sites and investigators because they are tailored to their patient population.
Outsourcing-Pharma (February 2019)
Steven Zdravkovic examines options for extractable and leachable studies to evaluate leaching from primary packaging into lyophilized drugs.
BioPharm International (February 2019)
John Watkins discusses investigational medicinal product dossier requirements for US sponsors planning to submit clinical trial applications in EU member states.
Regulatory Rapporteur (February 2019)
Kirsten Messmer outlines regulatory intelligence communication approaches for medium to large companies and highlights the advantages and disadvantages of each.
Regulatory Focus (January 2019)
Peter Lynch discusses regulatory changes in Australia that are designed to lead to earlier access to lifesaving medicines for patients.
Regulatory Rapporteur (January 2019)
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