Quality Systems

Articles

The European Pharmacopoeia is preparing for 2021 while also supporting the industry to develop vaccines and treatments for COVID-19.

EDQM Combats COVID-19 and Makes Plans for Future

Pharmaceutical laboratories must keep lab data integrity practices in mind in order to properly handle the effects of the COVID-19 pandemic.

Complying with Lab Data Integrity Practices During COVID-19

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Manufacturers and regulators accelerate R&D and production of new vaccines and therapies. 

Pandemic Brings Major Changes to FDA and Drug Development in 2020

Sean Milmo is a freelance writer based in Essex, UK.

The success of virtual GMP inspections performed during the pandemic may lead to more flexible opportunities in the future. 

Inspecting GMP at a Distance

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

After a difficult year, bio/pharma science delivers promising results.

Bio/Pharma, People, Perseverance, and Hope

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Virtual audits, virtual training, and more robust quality agreements may become positive impacts on the industry, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.


Impact of Pandemic on Permanent Procedures

FDA granted fast track designation for AB201, a small recombinant protein that is a potent, selective inhibitor of tissue factor, for the potential treatment of COVID-19. 

FDA Grants Fast Track Designation to ARCA biopharma’s Potential COVID-19 Treatment

The EC’s approval was based on positive results from a Phase III clinical trial that demonstrated a statistically significant and clinically meaningful improvement in patients compared to chemotherapy.

EC Approves Bristol Myers Squibb’s Opdivo in Second-Line Treatment of Esophageal Cancer

The EC’s approval comes after positive results from seven Phase II and III randomized, active-controlled, multi-center studies.

EC Approves Sanofi’s Meningococcal Meningitis Vaccine 

HMA and EMA have released a joint statement on the appropriate route for companies to submit marketing authorization applications and the approval processes for vaccines.

Regulatory Oversight and Compliance