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The Department of Industrial Policy and Promotion (DIPP) has released a statistic affirming Foreign Direct Investment in the region of pharmaceuticals and drugs. The value of investments will be around US $ 8.81 billion that comes to about Rs 48,828.3 crore in Indian currency. It is predicted that, the biotechnology industry will surpass 11.6 billion dollars by the year 2017

Course "Tougher Import Rules for FDA Imports in 2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and export program find that their shipment is delayed, detained or refused. In 2016 entries must use the Automated Commercial Environment (ACE) entry filing system or face entry refusals and monetary penalties up to $10,000 per offense. A number of other factors can derail the expectation of a seamless import process. The course covers detailed information about the roles and responsibilities of the various parties with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA's thinking and offer anecdotal examples of FDA's import program curiosities. Why should you attend: What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing. The FDA is steadily increasing the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment, your product is figuratively dead in the water. You must be accurate with the import coding information and understand the automated and human review process. If not, you can expect detained shipments. CBP is implemented a new "Automated Commercial Environment" computer program that changes import logistics and information reporting for FDA regulated products. Your shipment may be stopped before it is even loaded at the foreign port. What

Understanding Medical Identity Theft and ways of preventing it Medical Identity Theft is a common phenomenon in today's situation, where most health records are digitized. Although a lot of precaution goes into the security and protection of these records, Medical Identity Theft is a cause for worry. medicalIdentityTheft The most common types of data that are stolen are Social Security Number (SSN), name and the Medicare number, the most potent tools with which to impersonate and manipulate data. Why do crooks steal medical data? Medical Identity Theft happens mainly because hackers and mischief-makers access protected data to lay hands on confidential information about patients, using which they obtain medical care on behalf of the person/s whose records they steal or purchase expensive medicines. In many cases, a Medical Identity Theft is detected only after one gets a bill for a purchase or service that was never made. medicalIdentityTheft Medical Identity Theft is also committed to buy drugs and obtain fake bills that are then submitted to Medicare in the name of the original holder of the medical record. These acts can significantly dent a person's credit rating. More importantly, when wrong information or fictitious diagnosis is made into the medical record, it can lead to dangerous consequences. Ways of protection of medical data The Office of the Inspector General (OIG), which comes under Health and Human Services (HHS), realizing the gravity of the problem of Medical Identity Theft, has formulated the "3D" approach to protect medical data and prevent Medical Identity Theft. These are: Deter: One of the ways of protecting medical data is to prevent Medical Identity Theft. Users should be cautious about parting with information to anyone who claims, over phone, to have a new scheme whose enrolment requires the Social Security Number. Detect:Many fraudsters accost people at accessible public places to announce supposedly "new" medical schemes. Governm

Overview: The trial master file is a hard copy of all documentation relating to a clinical trial. It contains essential documents. When studies are conducted under ICH E6 Good Clinical Practices (GCP), this collection of documents must be present before, during and after the trial. These documents help provide quality assurance and help researchers evaluate their compliance with GCP, federal regulations and applicable laws. Why should you Attend: Anyone responsible for handling trial documentation or quality assurance activities. Areas Covered in the Session: Trial Master File (TMF): what is it? Essential documents required ICH guidelines and Good Clinical Practice (GCP) Food and Drug Administration (FDA) guidance and expectations Paper or electronic trial master files - what is allowable Links to useful resources Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Human Subjects Research Healthcare interested in exploring the field of Clinical Research New Clinical Research Coordinator positions (1-2 years) New Principal Investigator positions Administration in charge of Clinical Research Regulatory Compliance Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research manageme

Overview: Many infectious diseases were historically confined to specific geographical regions. However, some now pose global threats due to ease of travel, globalization of trade and commerce and global warming. Government Agencies, non-Profit Organizations, Philanthropic groups and others are also funding vaccination programs for regions where infectious diseases are endemic and to deal with new outbreaks.. Such developments are stimulating research in and the development of improved vaccines, their manufacture and control. Supply Chain complexities and stability issues need to be addressed to cope with transport of vaccines to and their use in climatically hostile regions. Programs to address such challenges need to be implemented, being resourced by appropriately trained and qualified staff from a number of disciplines. Development programs for immuno oncology products also require staffing by similarly skilled professionals. Workers currently engaged in Discovery, Development and Manufacture of conventional medications , or those seeking career-change opportunities can develop an understanding of the concepts, constraints and opportunities associated with Vaccine products by attendance at the Webinar. Engineering professionals involved in facility construction, or repurposing can also benefit as can Regulatory Affairs Professionals or staff at medicines Evaluation Agencies. The subject matter is particularly suited to professionals who are expert in the various disciplines associated with conventional medications ("so-called "small molecules") who wish to expand and develop their skills by involvement in vaccine-related programs including immuno-oncology. Areas Covered in the Session: History of and development of vaccine concepts. undamentals of vaccination Vaccine Types Administration of Vaccines Future Concepts Immuno-Oncology Vaccine Manufacture Who Will Benefit: Regulatory Affair Managers Project Management Personnel QA Managers Scientists Technol

Overview: Mental health care practitioners work in today's diverse, fast-changing, multidisciplinary health care environment. Nowhere but in mental health is there such diversity of clinicians who provide the same or similar services of counseling and therapy. A potential client has a wide choice of mental health providers from whom to choose. Yet each individual mental health profession has a unique education, training, and experience requirement for practice. While similarities exist, requirements differ from state to state and even from profession to profession with a single state. What are these requirements and how do they apply? The state's authority and power over mental health practitioners often presents challenges to these mental health professionals that are not easy to navigate. Differing sources of legal and ethical authority govern each respective health care practitioner in ways that are similar but not the same. Ethics and law are similar, but not the same. All mental health practitioners must adhere to standards of state law which govern their professional practices, including the very core of the doctor-patient relationship. Codes of ethics and state law may both apply to govern the conduct of this clinician. Even some state laws are referred to as ethical codes. Complaints as to alleged misconduct or ethical failings are received and investigated by a state agency and leave the mental health practitioner with an uncertain process to handle and to defend the state action against them. With this background, this seminar empowers the full understanding and application of ethics and laws for mental health practitioners. Learn to identify and understand an ethical framework for a sound mental health practice. An ethical framework is essential to having the right perspective to examine mental health dilemmas. Compare and contrast regulatory laws and codes of ethics to understand their differing applicability. Know the difference between laws and ethics,

Patient quality and safety in healthcare: Patient quality and safety are core aspects of healthcare. They need to be administered and assessed in the backdrop of a variety of factors. Many healthcare professionals see patient quality and safety in healthcare as being part of the broad canopy of healthcare. There is some disagreement and confusion as to the exact meaning of the terms patient quality and safety, but that is only when it comes to semantics. In broad terms, one can understand patient quality and safety in healthcare as efforts and steps and processes meant to improve the quality care given to patients. Patient quality and safety in healthcare relates chiefly to: Improving the safety of patients and augmenting the quality of health care in the various areas of health Bringing about a reduction in infections that are sometimes a byproduct of provision of health care Reduction in the incidence of adverse drug events Quality healthcare, of which patient quality and safety in healthcare are an integral part, is defined as "…doing the right thing, at the right time, for the right person, and having the best possible result" by The Agency for Healthcare Research and Quality (AHRQ). The AHRQ also describes patient safety as "the act of doing no harm", and which "…underlies all aspects of quality health care." Measuring patient quality and safety: Measuring patient quality and safety in healthcare is of utmost importance because no system or practice is meaningful unless it is capable of being measured. The level and success of patient quality and safety in healthcare is measured against the following parameters: How many patients who underwent surgery experienced infections? How many patients were required to be admitted for a second or subsequent time following discharge from hospital because of complications such as infections or recurrence of the problems for which the patient was admitted? To what extent did the healthcare

Tynor Hot and Cold Pack is a convenient device to provide hot fomentation or cold compress. Tynor Hot and Cold Pack is of multipurpose advantage. It is a convenient and effective approach for both hot as well as a cold therapy. Hot pack can be used for body ache, joint pain, etc., whereas a cold pack can be used for fever, sprains, fever, bleeding, etc. It is easy to use and maintains the temperature for a long period of time. It is available in 11.22 x 7.67 inch universal sizes. Hot fomentation of the injured or inflamed area enhances the threshold of pain and thus reduces the perception of pain. It has a synergistic effect along with pain relieving drugs. Raising temperature of the injured tissue also enhances the blood profusion and the healing process. Hot fomentation has a relaxing effect. Cold compress helps in reduction of inflammation in injuries, protects by slowing the metabolic rate around the tissue, reduce oedema and bleeding. Cold compress helps in immediately lowering fever, in very high fever conditions. It can be used after an acute injury or surgical procedure. No heat or cryo burns. Requires no holding. Reusable. Easy application. Appealing aesthetics. Tynor Hot and Cold Pack Features Multi functionality Reduce swelling and odema at the site of injury. Muscles spasm and pain. Headache and minor injuries. Versatile design Can be used as either cold or hot pack. Reusable in either hot & cold condition. Temperature range - Can be used from 0 Cº to 75Cº. Longer temperature retention time. Fabric cover ensures no cryo burns or hot skin burns. Physical features Non-toxic, and biodegradable. Gel remains soft and flexible upto 0 degree. Durable, and puncture resistant. Soft, "frost free" PVC cover. Flexible conforms to the body contours. Easy to clean and maintain. Excellent workmanship. Good aesthetics. Elastic belt Holds the pack against the body, No need to hold by hand. Enhances convenience. Tynor

Back issue is a standout amongst the most widely recognized motivations to see a specialist. According to a review, around 80% of individuals experience back torment amid their lifetime. Despite the fact that for the lion's share of these individuals the torment will die down actually without the requirement for surgery, while the staying still require appropriate care and drug or spine surgery to dispose of their back issues.

Overview: The Sunshine Act, or Open Payments Program, requires manufacturers of drugs, medical devices, and biologics that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. This Act was part of a healthcare reform bill adopted in March 2010. It came about due to requests for increased transparency about the financial relationships between physicians and industry. The Centers for Medicare and Medicaid (CMS) issued the final rules in 2013 which implemented the Sunshine Act. Why should you Attend: Anyone required to adhere to the Sunshine Act standards or anyone interested in knowing what must be reported and made public. Areas Covered in the Session: Purpose of the Sunshine Act Who is required to report under the Sunshine Act? What is reported? Exclusions Tracking Penalties Useful links Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Human Subjects Research Healthcare interested in exploring the field of Clinical Research Clinical Research Coordinators Principal Investigators/Physicians Administration in charge of Clinical Research Regulatory Compliance Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fu

CMS released the proposed Outpatient Prospective Payment System - OPPS rule for 2018- which includes a major proposed cut for separately payable drugs purchased under the 340B program.

Prevalence of cancer is on the rise throughout the world. Advanced therapeutics are being developed by pharmaceutical companies to address the growing burden of cancer. The time and costs associated with oncology drug development are also increasing; hence the key companies are collaborating with other pharmaceutical companies to reduce these costs.

Clinical Research Organization for Healthcare provides clinical-study and clinical-trial support for drugs and medical devices, wherein many pharmaceuticals, biotechnology, and medical device industries having operations in the Europe Union states outsource research services to CRO to increase efficiency and improve productivity.