GMP
Keeping tabs on Covid-19: Glucose monitoring technology donations, clinical pharmacology principles for vaccine developed, scaling viral vector-based vaccines scaled
June 12 by Emily UwemedimoExplore new strategies in health for helping individuals deal with social and physical distancing during the Covid-19 pandemic
Pharma & Biotech News Highlights Q3 2016
October 18 by Pharma IQ NewsFollowing a quarter that featured reports stating that Novartis had dramatically redistributed its cell and gene therapy unit 1 and saw the public focus turn once again to drug price hikes, Pharma IQ...
Pharma Regulations Landscape 2020
May 02 by Pharmaceuticals & Biotechnology EditorBeing prepared for how future legislation will change this industry and how current legislation will continue to shape the landscape is paramount to future planning. With this in mind Pharma IQ brin...
Legal Flash: 8 Regulations set to impact the Pharma & Biotech Industry in 2013
April 15 by Niamh MadiganPharma IQ has put together a list of 8 regulations and guidelines that look set to impact different divisions of the biotech and pharma industry in 2013. ONE: Good Distributio...
Increasing Inspection Coverage in the Wake of Globalisation; European Medicines Agency's Fergus Sweeney
March 08 by Fergus SweeneyIn support of our European activities, the European Medicines Agency (EMA) also has a role in the harmonisation of inspection procedures, and consequently we run clinical and manufacturing pra...
The 7 Deadly Sins of Quality Assurance and Quality Control
November 11 by Pharmaceuticals & Biotechnology EditorThe Seven Sins of QA and QC are those transgressions which are detrimental to quality and profitability. You will probably commit some of them every day. We asked the global pharmaceutical commu...
European Medicines Agency's Fergus Sweeney: Increasing Inspection Coverage in the Wake of Globalisation
November 07 by Pharmaceuticals & Biotechnology EditorWherever you sit in the world as a regulator, most of the clinical trials you receive in marketing applictaions, most of the manufacturing that takes place for products is taking place in terrioties...
Opportunities and Challenges for New Chinese GMP Compliance
September 30 by Pharma IQWhen the State Food and Drug Administration (SFDA) of China launched its new good manufacturing practice (GMP) guidelines in March 2011, it presented a list of new opportunities and challenges for w...
Managing Quality Relationships with CMOs is Critical for Success
September 15 by Pharma IQIn this Pharma IQ podcast, Diane Petitti, Vice President, Quality at Amylin Pharmaceuticals, speaks to Andrea Charles from Pharma IQ, about the current challenges relating to domestic and ov...
GMP Guidelines
September 05 by Pharma IQGood manufacturing process (GMP) guidelines are essential to ensure drugs are produced to a consistently high quality. GMP guidelines should be implemented at all stages of the manufacturing process t...
Scale-Up and Manufacturing of Regenerative Medicine
April 24 by William FodorWhen introducing a regenerative medicine cell based product to a commercial setting, there are a number of things to take into consideration to ensure a commercially viable and safe product for patien...
A Good Network is the Key to Overcoming Challenges in Comparator Sourcing – An Interview with Peter Orosz
April 24 by Peter OroszComparator sourcing is one of the leading difficulties in clinical trial supply today with those involved concerned about availability, limiting costs, reliability and shelf life. To further underst...