Viewpoints

Oct 02, 2018
Pharmaceutical Technology
Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.
Sep 17, 2018
By Pharmaceutical Technology Editors
In the second half of CPhI’s annual report, experts review industry trends and warn that trade and patent changes could increase healthcare cost by $100 billion over the next five years.
Sep 13, 2018
Advances in medicine and consumer electronics can enhance drug delivery and patient care.
Sep 01, 2018
Pharmaceutical Technology
The authors support the retiring of Ph. Eur. and USP heavy metal assays and propose a means of updating related specifications with minimal regulatory burden.
Aug 21, 2018
By Pharmaceutical Technology Editors
Experts from the Partnership for Research on Ebola VACcination report on progress and uncertainties regarding a safe and effective Ebola vaccine.
Aug 02, 2018
Pharmaceutical Technology
The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.
Aug 01, 2018
Pharmaceutical Technology's In the Lab eNewsletter
Managing data at the different stages of the lifecycle, linking disparate systems together, and making the right data available to those who need it is problematic and time consuming.
Jul 02, 2018
Pharmaceutical Technology
Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.
Jun 02, 2018
Pharmaceutical Technology
By minding knowledge gaps, bio/pharma companies can avoid development pitfalls.
Jun 02, 2018
Pharmaceutical Technology
Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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