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1-15 of 3738 results
NSF- A Final Word on KPIs – A Case Study From a Site Quality Head
Leadership had mixed views of KPIs. Many did not distinguish between leading and lagging, and none focused on behavior first, measure second. We set out to address these issues.
Regulatory Affairs > Case Studies
NSF asks a Production Director for their views on moving forward with KPIs
| By NSF Health Sciences Pharma Biotech PBR
KPIs and the Production Director: Select Fewer, More Significant KPIs and Set Goals for Your Metrics
Regulatory Affairs > White Papers
NSF determines what KPIs mean for Employees
| By NSF Health Sciences Pharma Biotech PBR
KPIs and Employees: Involve Us Upfront and Let Us Help Define Relevant Measures
Regulatory Affairs > White Papers
NSF asks ex-MHRA Inspector about the Importance of KPIs and gets Interesting Results
| By NSF Health Sciences Pharma Biotech PBR
KPIs and the Regulator: I’m Looking for Quality Metrics, Management Review and Continual Improvement.
Regulatory Affairs > White Papers
Genentech's Rituxan gets FDA breakthrough therapy status to treat pemphigus vulgaris
By PBR Staff Writer
Roche’s subsidiary Genentech has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its Rituxan (rituximab) to treat pemphigus vulgaris.
Regulatory Affairs > News
Amgen’s Amgevita secures approval in Europe for certain inflammatory diseases
Amgen’s Amgevita (biosimilar adalimumab) has been granted the marketing authorization by the European Commission (EC) in all available indications.
Regulatory Affairs > News
Merck, Pfizer get FDA nod for Bavencio to treat metastatic Merkel cell carcinoma
By PBR Staff Writer
Merck’s EMD Serono and Pfizer have secured approval from the US Food and Drug Administration (FDA) for Bavencio (avelumab) injection 20 mg/mL to treat metastatic Merkel cell carcinoma (mMCC).
Regulatory Affairs > News
NSF: What Does Your Company QMS Look Like? Where Does Senior Management Fit In?
NSF was asked by top management to review the range and extent of GxP quality systems in place and make recommendations for a single company-wide QMS suitable for its modern business model and meeting all anticipated regulatory requirements.
Regulatory Affairs > Case Studies
NSF: Does Your Pharmaceutical Quality System Improve Your Competitive Edge?
There are some companies who believe that their Pharmaceutical Quality System (PQS) exists purely for regulatory compliance. We think this attitude is outdated and plainly wrong. At NSF, we believe that your PQS has only one purpose: to improve your competitive edge by guaranteeing the manufacture of high quality medicines at the lowest possible cost. We have worked in partnership with many of our clients to help them improve their PQS and their competitive edge. The following results give you a flavor of what can be achieved and how.
Regulatory Affairs > Case Studies
Tech Talk: CHANGING GMP BEHAVIORS with NSF
| By NSF Health Sciences Pharma Biotech PBR
Most people are content sticking with what they know and their tried and tested habits. It’s easy. To get people to think and act differently (a painful process for most), you have to provide them with the motivation.
Regulatory Affairs > White Papers
Akashi gets FDA nod to restart clinical development of DMD drug HT-100
Akashi Therapeutics has secured approval from the US Food and Drug Administration (FDA) to resume clinical development of HT-100 (delayed-release halofuginone) in patients with any of the genetic mutations that cause Duchenne muscular dystrophy (DMD).
Regulatory Affairs > News

PBR Supplier Recommendations

SHL Group - Pen Injectors, Autoinjectors and Inhaler Systems
SHL is a privately-owned developer, designer and manufacturer of advanced drug delivery devices.... Regulatory Affairs > Suppliers
NSF Health Sciences Pharma Biotech
NSF International’s pharma biotech services include world-class regulatory and compliance consulting, auditing, residential and on-site pharmaceutical training and clinical testing on a global basis. ... Regulatory Affairs > Suppliers
Vaisala - Supplier of Continuous Monitoring Systems for Controlled Life Science Environments
Vaisala is a world leader in environmental and industrial measurement systems and instrumentation. We offer measurement instrumentation, continuous monitoring systems and validation systems to measure and supervise environmental conditions, within regulated or controlled life science environments.... Regulatory Affairs > Suppliers
Rentschler - High-Performance Biopharmaceutical Development and Manufacturing
Identifying the most appropriate contract manufacturer who can best fulfil what you need for your lead pharmaceutical candidate is a real challenge. With over 40 years’ experience, Rentschler is one of the industry leaders for contract development and manufacturing.... Regulatory Affairs > Suppliers
ERT - Getting it done. Right.
ERT is a leading global provider of high-quality patient safety and efficacy endpoint data collection solutions for use by biopharmaceutical companies during clinical drug development. ERT delivers a combination of technology, services, and consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process throughout the product lifecycle.... Regulatory Affairs > Suppliers
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PBR White Paper Recommendations

NSF - Site Director: KPIs Should Look Forward as well as Measure Results By NSF Health Sciences Pharma Biotech PBR
A Site Director expresses his views on how to use KPIs most productively. ... Regulatory Affairs > White Papers NSF asks a Production Director for their views on moving forward with KPIs By NSF Health Sciences Pharma Biotech PBR
KPIs and the Production Director: Select Fewer, More Significant KPIs and Set Goals for Your Metrics... Regulatory Affairs > White Papers NSF determines what KPIs mean for Employees By NSF Health Sciences Pharma Biotech PBR
KPIs and Employees: Involve Us Upfront and Let Us Help Define Relevant Measures... Regulatory Affairs > White Papers NSF asks ex-MHRA Inspector about the Importance of KPIs and gets Interesting Results By NSF Health Sciences Pharma Biotech PBR
KPIs and the Regulator: I’m Looking for Quality Metrics, Management Review and Continual Improvement.... Regulatory Affairs > White Papers Tech Talk: CHANGING GMP BEHAVIORS with NSF By NSF Health Sciences Pharma Biotech PBR
Most people are content sticking with what they know and their tried and tested habits. It’s easy. To get people to think and act differently (a painful process for most), you have to provide them with the motivation.... Regulatory Affairs > White Papers See more
1-15 of 3738 results