Life is a Journey..how to make the best of it!

BayBiotech.NET This blog is focused on discussing some of the terminology you may come across while dealing with Quality Control/Assurance or regulatory compliance in a Pharmaceutical/ Life sciences Industry environment. We may not dedicate many blogs on this, but briefly going over them, will provide us the acquaintance with theses terms and may help understand them better whenever they are referenced in other documents/ blogs. These are as follows: Pharmaceutics: discipline of pharmacology that involves evaluation, design and preparation of suitable dosage forms of chemical entities and delivery systems. This discipline is targeted towards optimizing drug action as well as minimizing adverse effects. Pharmaceutics involves studies from interdependent areas such as physical chemistry, biochemistry, analytical chemistry, mathematics, chemical engineering, molecular and cellular biology, pharmacology, anatomy and physiology. Pharmacokinetics: is the study of the time course of d

BayBiotech.NET We often think of clinical trials as a principle method of studying new drugs, but there are many different types of trials that are designed to answer different questions related to health care and well beings of the human subject. Understanding the objective of your clinical trial and the entire process is the first step taken towards determining the regulatory pathways that will apply to a particular study. Depending on the end-goal different types of clinical trials are as under: • Prevention trials – Prevention trials look at substances and lifestyle factors that may raise or lower the risk of developing a clinical condition. e.g. effect of a particular type of food or exercise on preventing Diabetes. • Screening trials – Screening trials are designed to diagnose a condition in its early stages when it is often more curable. e.g. a newly developed imaging technique if used to screen breast cancer occurrence. • Diagnostic trials – Diagnostic trials are aimed

Quality Assurance and Compliance: Industrial Environmental Management Systems BayBiotech.NET

BayBiotech.NET AERS is a computerized information database designed to support FDA’s post marketing safety surveillance program for drug and biological products. The AERS database is used to store and analyze data received in post marketing safety reports submitted in form of reports by companies. FDA recently proposed to submit the reports in electronic format in order to achieve the following objectives: 1. Eliminate the time and costs associated with submitting paper reports. 2. Expedite the agency’s access to safety information 3. Enhance agency’s ability to rapidly communicate information about suspected problems to health care providers, consumers, applicants, and sponsors within the United States and internationally. The proposal is developed considering international standards guidelines (ICH) and was open for public comment between August- November, 2009. To read more about the proposed rules follow the link: http://edocket.access.gpo.gov/2009/pdf/E9-19682.pdf

BayBiotech.NET Environmental Management Systems (EMS) can be considered as a tool to manage the environmental quality policies and procedures as per Industry standards and regulatory guidelines. EMS provides a framework to efficiently operate organizational responsibilities and activities in most efficient ways keeping the risk to the environment at its minimum. EMS also provides scope to the organization to implement corrective and preventive plan in order to continuously improve the environmental performance. An effective management system ensures that adequate efforts are properly deployed in regard to training, monitoring and reporting. Three main environmental guidelines that fall within the scope of Biotech/ Life Sciences Industry and will need integration with EMS are: RC14001: Responsible Care® (RC) is a voluntary initiative of the worldwide chemical industry with a focus on an on-going efforts to improve the safety and the protection of health and the environment, applic

BayBiotech.NET The Health Information Technology for Economic and Clinical Health Act ( HITECH), intended to promote adoption of information technology for maintenance of electronic health records and incorporated into the American Recovery and Reinvestment Act of 2009, was signed into law on Feb. 17, 2009. The key points of the provisions are: 1. Tracking the medical information disclosure: According to the new legislation, physicians will be required to track any disclosure of a patient's medical information. Previously regulations allowed physicians to disclose patient information for the purpose of treatment, billing or health care, but they were not required to track when that information was disclosed. This provision kicks in for current users on Jan. 1, 2014, and then patients will be able to request an accounting of disclosures of their electronic personal health information three years from the date of the request, potentially dating back to 2011. 2. Rules regarding s

BayBiotech.NET When ICH was conceived in 1999, it was for a good cause understanding that it will have harmonization on guidelines for conduct of a clinical trial worldwide as it brought together European Union, United States and Japanese experts together to draw a set of standards that would streamline the clinical research globally. Out of thirty-eight topics (Guidelines) originally identified, only the ICH E6 document relates to the standards of Good Clinical Practice. Since, the EU Directive were set in place for conducting a clinical trial in UK and European member states it is not only ICH E6 but also EU GCP Directive 2001/20 and 2005/28 that is required to be followed which gives a higher standard than ICH E6 alone. Apart from these directives, member states of the European States have their local laws that are also incorporated into the GCP conducts. This further complicates the conduct of clinical trials and acceptance of global data because if a member state selects a site