Holding Out Hope

Holding out hope

Stephen Peroutka talks about the challenges related to assessing and evaluating depression.

DDNews  (April 2019)

Going global in biopharma regulatory affairs

Alistair Davidson, Patricia Hurley and John Watkins discuss the growth of international products and the ensuing need for regulatory harmonization.

BioPharm International  (April 2019)

Regulatory intelligence communication for business impact

Kirsten Messmer and Charity-Anne Schuller discuss how to maximize regulatory intelligence and offer best practices recommendations.

Regulatory Focus  (March 2019)

Wearables In clinical trials

Rob Petrie comments on some of the keys to the successful use of wearables in clinical trials.

PharmaVOICE  (March 2019)

FDA’s oncology clinical trial makeover

Pat Mann, Kirsten Messmer and Luis Arthur Pelloso provide an overview of new FDA guidances related to oncology drug development.

Regulatory Focus  (March 2019)

Applying for an EU marketing authorisation: A pharmacovigilance perspective

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)

PPD inks deal with China’s HLT to create data science-driven research solutions

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)

PPD signs exclusive agreement with China-based AI company

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)

Understanding Leaching from Stoppers into Lyophilized Drugs

Steven Zdravkovic examines options for extractable and leachable studies to evaluate leaching from primary packaging into lyophilized drugs.

BioPharm International  (February 2019)

The CMC section of an EU IMPD: Considerations for US sponsors

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)

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