Tag Archives: access

  • WHO Ebola Vaccine Meeting

    … many complex policy issues that surround eventual access to experimental Ebola vaccines. Ways to ensure the fair distribution and financing of these vaccines were discussed in an atmosphere characterized by a high sense of urgency. This sense of urgency was conveyed in many ways – from plans for the different phases of clinical trials to be performed concurrently rather than consecutively, to suggested partnerships for expediting clinical trials, to proposals for getting all development …

  • Pharmaceutical Consultants-The Key to a Rapidly Changing Industry

    … performance, and enhance the quality of pharmaceutical products. Consultants can also provide solutions for the manifold certification and approval processes required by the government and other official entities for healthcare products and services. Smart Consulting Group operates on the understanding that the client-consultant relationship is a partnership that promotes finding the best solutions to achieve the desired business objectives. With Smart Consulting, “you will have access …

  • 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 …

  • Diabetes Trends Until 2025

    … rapidly becoming one of the most important areas in the pharmaceutical industry, and from 2010 until 2025, the market’s growth will speed up dramatically. Following are some indicators that reveal the future of the diabetes market and that are the focus of pharmaceutical consultants and their top clients: -The diabetes market will have access to highly superior diabetic products. -Research and development for diabetes therapies will center on technologies that enhance clinical …

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

    … published in the open access journal PLoS Genetics, shows that a gene called ‘Smed-prep’ is crucial for the correct regeneration of the head and brain of planarian worms. These worms have an incredible ability to regenerate body parts.  They contain adult stem cells that are incessantly splitting and are able to become all of the missing cell types; they have the correct set of genes at work to achieve this in the right way, so that when the body parts grow back, it happens in the right …

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

    … and published in the open access journal PLoS Genetics, shows that a gene called ‘Smed-prep’ is crucial for the correct regeneration of the head and brain of planarian worms. These worms have an incredible ability to regenerate body parts.  They contain adult stem cells that are incessantly splitting and are able to become all of the missing cell types; they have the correct set of genes at work to achieve this in the right way, so that when the body parts grow back, it happens in …

  • Glaxo and Pfizer Will Provide Pneumonia Vaccines

    … that are affordable could save 900,000 lives by 2015 and 7 million lives by 2030. Glaxo will deliver 30 million doses and Pfizer an equal amount, for the next 10 years. Pfizer is enhancing its manufacturing capacity to meet the global demand and to deliver Prevenar 13, which can be used in infants and small children throughout more than 40 countries. Jeffrey Kindler, Pfizer Chairman and CEO, affirmed that, “Pfizer is dedicated to broadening access around the world to our medicines, and …

  • Growing Cooperation between Big Pharma and Patients

    … innovation to the payer-provider relationship, the botton line is, they still have to make money.  Because of ever increasing competition from oversees, not to mention increasing price pressures and growing market access restrictions, this process is proving far more difficult than previously imagined. While both sides are working hard to come up with the best solution, the common consensus is that starting a healthy dialogue is key.  Through this healthy dialogue consumers as well as the …

  • The Marriage between Big Pharma and Mobile Technology

    … devices as an effective solution to help overcome these obstacles. It may be surprising to hear, but mobile technology is actually taking center stage when it comes to advancements in the pharmaceutical industry.  Compared to other industries where mobile technology is being utilized, high tech mobile solutions are playing key roles in the overall growth of the pharmaceutical industry as a whole.  Mobile technology also helps personnel and researchers more easily access protocols, as well as …

  • CDER’s Small Business Assistance Bulletin

    … and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability between thelocal regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. http://edocket.access.gpo.gov/2009/pdf/E9-30441.pdf and http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073427.pdf 2. Amendment of the Informed Consent Regulations. The Food and Drug Administration …

  • Pharmaceutical Marketing Strategies towards Physicians Are Not Trusted

    … consultancies, membership to advisory boards, and stock holding.  Extravagant gifts and travel aid have been the center of attention in the past; however, these have been inhibited by the industry and professional codes.  Now we are seeing that regular, more modest, sponsored events may become more influential, and the main point of contact between pharma and doctors. The Australian information is quite difficult to access.  Summary reports listing each function should be easily accessible to …

  • Be Prepared When the FDA Knocks on Your Door

    … that could attract the FDA’s attention before this happens.  Some examples are potential contamination, under maintenance, and unclean areas. 3. Select key people to accompany the FDA official Train two or more employees who supervise the major processes to follow the FDA official.  Teach them how to treat and interact with this person. 4.    Write an operations manual Operations manuals should be the main reference in the facility.  Employees must have continuous access to them in …