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

BayBiotech.NET Recent FDA Amendments Act of 2007 has emphasized needs of active adverse event surveillance methods linking multiple sources of clinical data for analysis and further mandates creation of effective tools for post market risk identification, assessment and management of adverse events. Legislation recognizes the limitations of traditional mainstream drug safety practices in the pharmaceutical industry that depends on the collection and analysis of safety data from clinical trials and therefore emphasizes the need of data mining from multiple sources. In past few years, emerging need of data mining has generated lot of interest among various competitors to develop tools within the limits of privacy and confidentiality limits to meet the drug safety needs. FDA is in the process of currently exploring, testing, and developing new methods of signal detection, data mining, and analysis of patient-level electronic healthcare data hoping that these new developed methods will

BayBiotech.NET Following is a summary of the key points on the laws, regulations and Good Clinical Practices of the Member States as per European Union’s Directive for conduct of Clinical Trials on human subjects: 1. Directive requires that applications for authorization to place a medicinal product on the market should be accompanied by a dossier containing particulars and documents relating to the results of tests and clinical trials carried out on the product. A dossier must be prepared in compliance with uniform rules laid down by the Member States. 2. A detailed risk assessment and management strategy must be in place based on the toxicological data derived at Pre-clinical research stage. 3. Persons who are incapable of giving legal consent such as dementia, psychiatric patients etc. to clinical trials should be given special protection. Such persons may not be included in clinical trials if the same results can be obtained using persons capable of giving consent. These

BayBiotech.NET Health Insurance Portability and Accountability Act of 1996 (HIPAA, Title II) required the Department of Health and Human Services (HHS) to establish national standards for the security of electronic health care information. Department of Health and Human Services prepared certain guidelines that specify a series of administrative, technical, and physical security procedures for covered entities to use to assure the confidentiality of electronic protected health information (EPHI). This is particularly relevant for organizations that allow remote access to EPHI through portable devices or on external systems or hardware not owned or managed by the covered entity. Guidelines address mainly the privacy of health information issues that may arise by using laptops; home-based personal computers; PDAs and Smart Phones; hotel, library or other public workstations and Wireless Access Points (WAPs); USB Flash Drives and Memory Cards; floppy disks; CDs; DVDs; backup media; E

BayBiotech.NET The European Commission’s Directive on Data Protection w.e.f.October of 1998 prohibits the transfer of personal data to non-European Union nations that do not meet the European “adequacy” standard for privacy protection of the personal data. For purposes of the policy, "personal information" means information that:  is transferred from the European Union to the United States;  is recorded in any form;  is about, or pertains to, a specific individual or can be linked to that individual. While both the United States and the European Union share the goal of enhancing privacy protection for their citizens, the United States takes a different approach to privacy from that taken by the European Union. With a goal to bridge the different privacy approaches between the United States and European Union and provide a streamlined means for U.S. organizations to comply with the Directive, the U.S. Department of Commerce in consultation with the European Commissi

BayBiotech.NET FDA launched its Critical Path Initiative (CPI) in March 2004, with the release of a report “Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products”. This report highlights the reasons for the widening gap between modern scientific discoveries with a potential to prevent and cure some of today's biggest medical challenges, and their translation into innovative medical treatments. The main reason identified was being Industry’s apprehension to adapt and train to new technologies that might delay launch of the product into the consumer market. In order to ease out the apprehension, FDA recognized the need for a collective action to modernize the scientific and technical tools and introduced CPI and calls for incorporating specific activities into the medical development path that would help modernize the critical path sciences. CPI has seen the number of its projects grow from 40 in 2006 to 95 in 2009. FDA is collaborating wi

BayBiotech.NET Before the onset of a trial the study director/sponsor must have a risk assessment and risk management plan to accompany the filing to IRB or FDA for IND or PMA applications. Hazard is defined as anything that could cause harm and risk is the probability of that harm caused by the hazard. Risk Assessment Plan for each potential hazard includes mapping and analysis of associated risks, its potential consequences and reasonable steps to reduce the risks. In a clinical trial hazards are categorized into main four groups: 1.     Hazards for the participants that encompasses protecting participant’s rights. 2.     Hazards for the participant’s safety by assessing the likely risk/ benefit ratio in the study population. 3.     Hazards of the trial with risk associated for recruitment and follow-up. 4.     Hazard to the reliability of the results mainly in terms of study power and adherence to the protocol. Risk Management Plan includes detailed strategies and

Quality that Matters for Life Sciences Venture: Risk Evaluation and Mitigation Strategies Guidance for Pharmaceutics and Biologics BayBiotech.NET