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

BayBiotech.NET Scope: the policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research. This policy does not affect any state, local or foreign laws or regulations which may otherwise be applicable and which provide additional protections for human subjects. Exclusions:  Research conducted in educational settings, examples: research on education instructional strategies, on comparison among instructional techniques, curricula, or classroom management methods.  Research involving survey procedures, interview procedures or observation of public behavior, unless information is recorded in such a manner that human subjects can be identified.  Research involving the collection of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or

BayBiotech.NET Pharmacovigilance is a branch that involves the identification and evaluation of safety signals generated by the usage of a medical product. Safety Signal: is a concern raised when excess of adverse events are observed compared to what would be expected with a product's use. Signals can arise from collection of post marketing data, preclinical data and events associated with other products in the same pharmacologic class. Even a single well-documented case report can be viewed as a signal, particularly if the report describes an event that is extremely rare in the absence of drug use. Signals indicate the need for further investigation, which may or may not lead to the conclusion that the product caused the event. After a signal is identified, it should be further assessed to determine whether it represents a potential safety risk and whether other action should be taken. Good Pharmacovigilance Practice is based on acquiring complete data from spontane

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