Tag Archives: regards

  • Risks in Lean Compliance

    … risks is what truly gets people talking and from there brilliant ideas are drawn up. Now, in the biopharmaceutical industry going lean is all about taking risks and understanding that risk. So what about the 80:20 rule you may ask? What’s all of the fuss about in regards to identifying risk in lean compliance? Let’s try and wrap our brains around this concept a bit. “Risk is a balance of certainty and uncertainty, in addition to the probability of something occurring.” It’s vital to …

  • FDA Inspection Wizard: What’s Scary Can Turn Out to Be a Piece of Cake

    … of clinical studies outside of your specialization field _ The reporting of much better effectiveness, less unfavorable effects, or different laboratory results from other sites studying the same drug _ Having noticeable access to a large number of patients with a specific disease state for the setting _ Complaints from a patient or sponsor in regards to regulations, protocol, or human rights violations -Customer complaints that may trigger a product recall How it all starts It all starts with a …

  • The Secret to Tissue Regeneration… In The Body of a Worm?

    Scientists from the University of Nottingham have uncovered the gene that allows an amazing worm to regenerate its body parts after these have been amputated; and we’re talking about even its whole head and brain! The discoveries made about the Planarian worm could be a huge step forward into one day seeing real results in regards to the regeneration of old or damaged human organs and tissues. For the first time, this research, headed by Dr. Aziz Aboobaker, a research Councils UK Fellow, and …

  • How to Perform a Mock Audit

    … character” throughout the whole process to get the best out of the activity. It can be educational to invite managers, executives, and members of other projects to observe the mock audit; and it is because of the educational aspect that the mock audit requires immediate and thorough review of the lessons learned after it is finished. The review process has to include: -Comments from the mock inspector in regards to what was done well and what needs improvement. -Observations from the QA …

  • The Secret to Tissue Regeneration… In The Body of a Worm?

    Scientists from the University of Nottingham have uncovered the gene that allows an amazing worm to regenerate its body parts after these have been amputated; and we’re talking about even its whole head and brain! The discoveries made about the Planarian worm could be a huge step forward into one day seeing real results in regards to the regeneration of old or damaged human organs and tissues. For the first time, this research, headed by Dr. Aziz Aboobaker, a research Councils UK Fellow, …

  • Management Responsibilities and Automation Techniques in Regulated Pharma Environments as Per a Suggested Quality System Model

    … There are five stages linked to Quality System maintenance: 1.Observation of the Quality System 2.Identification of deviations and nonconformance events 3.Reporting 4.Analysis 5.Appropriate action Management has to be accountable for every stage of Quality System maintenance and normally will hold the biggest responsibility in regards to data analysis and later decision making. In spite of this, it is common to see managers spending most of their energy on the first three levels, which are the …

  • Guilty as Charged: The Premature Stop of Clinical Trials Exaggerates the Effects of Treatment

    … one of the authors of the study, explained that they discovered that in the majority of cases where the clinical trial was stopped prematurely, the effects of the treatment were deceptive, and that these ambiguous estimations will most probably produce unwise decisions in regards to the estimation of the therapy’s risks and benefits. He added that, “On average, treatments with no effect would show a reduction in relative risk of almost 30 percent in stopped early trials.  Treatments …

  • The Role of Interim Monitors in Divestitures

    … associated with mergers in highly regulated and complex industries, the Federal Trade Commission (FTC) has the power to include special provisions in a Consent Order to appoint an individual, known as an interim monitor, to oversee the operation.  The FTC regards the interim monitor as the eyes and ears of the FTC and is required to watch all of areas of the merger or acquisition and identify any issues that may arise which may hinder an independent and effective competitor from being …

  • Adult Stem Cells Show Potential for the Treatment of Cardiac Patients

    … scientific method, and close to a million United States’ citizens suffer heart attacks each year. These results will put to rest some of the discussions in regards to clinical stem cell research for heart disease.  Although many think that it is too soon to test stem cells in patients, this study has proven the value of exact and controlled clinical trials. In doing so, it also establishes the basis for the development of novel cell heart therapies. Many believe that this trial acts as a key …

  • Patient Safety Resides in Global Thinking

    … a full supply chain pedigree system encompasses. Currently there are two main initiatives that are fragmenting the resources of the industry: The European Federation of Pharmaceutical Industries and Associations (EFPIA) initiative, and the California ePedigree network.  Not long ago, the pharma industry overcame many years of irrational enthusiasm in regards to the near-term potential of RFID technology.  It is time to learn from mistakes and select an approach that leads to improvements in …

  • The Global Vaccines Market, 2008-2023

    … The Global Vaccines Market report focuses on these aspects within the field of vaccines: –    Sales projections for vaccines by disease area, brand and country, including new therapeutic vaccines –    Analysis of strengths, weaknesses, opportunities, and threats in regards to the vaccine industry –    Expert opinion from key leaders in the field –    In-depth analysis of the vaccine pipeline –    Analysis of the prospects for therapeutic vaccines …

  • Be Prepared When the FDA Knocks on Your Door

    … to see the top management person on site, and he will show his credentials and an FDA ‘Notice of Inspection’ to that person.  Afterwards, a thorough inspection of the facilities will begin, while one or more key employees tag along.  After a few days, the FDA will send an ‘Inspectional Observations form’ to the leadership team informing them about any unacceptable conditions they have found in regards to products, processes, or other violations to the FD&C Act. The results of such …