Viewpoints

Steep price increases for a popular drug have created patient and Congressional backlash.

Congressional partisanship creates noise, but no funding for Zika virus research.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses standard operating procedures for the regulatory affairs department.

CPhI Pharma Awards seek nominations for excellence in development and manufacturing.

Process analytical technology paved the way for continuous manufacturing.

With technology advances, continuous manufacturing shows steady progress to more widespread adoption.

Pharma has voiced strong opposition against Britain’s departure from the EU.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.

Policies for patient access to life-saving therapies must keep pace with biomedical innovation.

Pharma understands the importance of patient centricity, but the problem is the gap between intent and action.

By focusing on laying strong technology foundations, pharmaceutical businesses can make informed decisions, equip themselves with the capabilities to eliminate threats, and future-proof operations.

Pharma companies must weigh cost efficiencies of global API sourcing with increased complexities of monitoring for compliance and quality.

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss requirements for successful product technology transfer.

A global API marketplace increases the burden of supply chain monitoring for drug companies.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how the regulatory requirements for CGMPs is the different phases of drug development and manufacture.

Thought leaders tackle drug shortages and manufacturing innovations.

Suppliers must develop new technologies to drive the bio/pharma innovation engine.

Infrastructure and payer decisions will determine drug choices in emerging and developed regions.

Employers have work to do to improve job satisfaction and retain qualified workers.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to ensure archive records can be retrieved.

The CPhI Pharma Awards celebrate innovations in the pharma industry.

A CPhI report suggests that the pharma industry should be careful not to outsource to lower labor-cost countries rather than investing in manufacturing technology and innovation.

A CPhI report predicts how two potential mega free-trade deals, one among Pacific-Rim countries and the other between the US and EU, could affect pharmaceutical companies.

In the development of biopharmaceuticals and pharmaceuticals, the line is blurring.

CPhI’s Annual Report discusses the implications of QbD, continuous processing, excipient criticality, and process validation on pharmaceutical manufacturing and predicts a steady shift to continuous manufacturing.

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.

Worldwide, meetings take place for several reasons, such as to share new findings, learn about novel technologies, discuss international issues, exchange know-hows, and network, to name a few. While each of these reasons has its significant importance, what really matters in scientific inquiry is progress.

Ensuring data integrity involves effort on an individual and global basis.

This special issue combines technical articles on leading pharma industry topics and a comprehensive preview of the upcoming CPhI Worldwide trade show

*This article is an opinion piece and does not necessarily represent the views of BioPharm International.