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A renowned ophthalmic surgeon highlights the rationale for the appropriate off-label use of ophthalmic medications and explores the adverse impact of government ‘off-label’ policies as it relates to the traditional practice of dispensing professional drug samples.

Both government and the medical profession view peer review as an important tool in advancing the quality of health care. Medical peer review takes place in a variety of settings and phases, can be triggered by incident reviews and complaints, and is best conducted when formally structured within an organization, utilizing ethical principles, evidence-based clinical standards and, in corrective action cases, appropriate due process, in order to foster candid professional self-assessment. Leg...

Managed Care increased in popularity as third-party payors and government agencies became more concerned with rising healthcare costs. Hardly any area of healthcare is free from its impact. Historically, review of medical claims was the responsibility of corporate Medical Directors possibly reviewing cases outside their specialty area. Today, the standardization of utilization management activities by state regulations and utilization review accreditation organizations encourages the use of ...

This two-day course has been developed for those who are involved with ensuring regulatory compliance for medical devices. The course is primarily geared towards those who are new to industry or require a basic understanding of medical device regulatory compliance issues, but is valuable to anyone looking for a refresher or a means to stay current with regulatory agency thinking. The course content is designed to provide an in-depth understanding of the paths to obtaining agency approval; ho...

This course is designed for personnel who are responsible for understanding Japan’s regulatory environment and business practices within the Pharmaceutical and Biotechnology industries. Individuals with responsibility for ensuring compliance with regulatory filings and adhering to overall regulatory requirements will also find this training highly relevant . Additionally, this training program will provide detailed knowledge to business development professionals seeking to either licen...

This course will review a process for closing the gap between regulatory requirements and study execution. Participants will acquire strategies for risk management in the areas of regulatory compliance, protocol execution and participant safety. Guidance documents important to pediatric research will be reviewed within the context of case studies from completed programs. Participants will be given an opportunity to share their experience during working sessions on protocol design and ethical i...

This educational activity will outline the basic regulatory requirements regarding the proper handling and disposal of pharmaceutical hazardous waste and the background needed to understand the regulatory scheme and regulatory “triggers” so you can determine which regulations apply to these compounds. We will outline potential penalties for non-compliance regarding the proper handling and disposal of pharmaceutical hazardous waste. We will also discuss NIOSH listed hazardous drugs (chemo...

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil, Chile, Costa Rica, Dominican Republic, Mexico, Panama, Peru and Venezuela. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of regulatory agencies in Latin America. Content will...

CMC regulatory compliance deficiencies have resulted in clinical holds and delays in market approval. Additionally, CMC regulatory shortfalls in marketed products have also resulted in FDA Warning Letters and product recalls. Insights and practical suggestions to develop and manage CMC regulatory compliance for biopharmaceuticals and biologics are presented in this class. This three-day course will also present a strategy to obtain a cost-effective, risk-managed CMC compliance strategy partic...

This course will give participants the necessary overview of the applications and procedures used within Europe to grant marketing authorizations for medicinal products, as well as, the agencies and institutions which control the regulatory process. While special focus will be given to the European Medicines Agency (EMA) and its centralized procedure, the role of localized national health authorities and other EU bodies will be discussed in depth. The course will also cover topics relating t...

Healthcare data breaches and medical identity theft are among the fastest growing categories of data loss in the country. Traditional access controls - physical and technical - fail to provide adequate safeguards. Most organizations still do not have the level of system or data awareness needed to even know when data-rich assets may go missing or unauthorized access to or disclosure of ePHI is occurring. Most organizations are wholly unaware of the ever-changing threat landscape or whether t...

This course reviews administrative, physical, and technical safeguards mandated by the HIPAA Security requirements; describes required policies and procedures; and introduces the basic concepts of information security.

mployers continue to push through the toughest economy in decades, awash with a tsunami of EEO charges and employment lawsuits, fighting the tidal wave of wage and hour claims, and adjusting to a regulatory-focused administration in Washington. Staying ahead of the trends is the best means of protecting your organization in a time of unprecedented employment law risk, legislative and regulatory activity. This seminar guides you through a multitude of employment issues, to better focus your com...

The purpose of this scientific conference is to identify and discuss the latest knowledge and important issues on the health effects of isocyanates, including current best evidence about exposure monitoring, environmental controls and clinical management. Conference Themes - Call for Papers • Worker and consumer protection issues • Environmental exposure/monitoring • Occupational health surveillance/management • Toxicity testing/animal models/biomarkers • Respiratory epidem...

The spring 2009 influenza outbreak drew attention to some aspects of influenza and the multiple areas of interactions that should be addressed when considering its epidemic potential. Preventive care is a critical component of controlling influenza infection. Prevention should be a combined effort between care providers, public health agencies, government, the media, and the public.

**Objectives:** * Identify the clinical, legal, or educational issues encountered by infection preventionists and epidemiologists * Describe the effect of infection control and prevention issues on nurses, hospitals, or the health care industry in general * Cite solutions to the problems encountered by infection preventionists, based on guidelines from the relevant regulatory authorities, and/or independent recommendations from clinicians at individual institutions.

To better understand what the developing FDA biosimilar pathway might look like, this course will examine closely the existing regulatory guidelines from the European Medicine Agency (EMA) and the World Health Organization (WHO) and compare them to the draft FDA guidances. Insights and practical suggestions to help your company enter the biosimilar biological product market will be provided by examining what has worked, and what has not, for the existing market-approved EMA biosimilars and FDA...

During the latter days of the presidency of George W. Bush, the Medicare, Medicaid, and SCHIP Extension Act (MMSEA) became law. This law has profound implications for physicians (and other healthcare workers and facilities) who treat Medicare patients. In attempting to help the federal treasury recover the monies it is due in certain situations in which Medicare is or was a “secondary payer,” MMSEA imposes reporting requirements on those considered primary payers physicians, clinics, and ...

This two-day course is designed for all persons who are involved in the management of pharmaceutical, biopharmaceutical, and biologics Quality Control Analytical Laboratories. The course will also be of benefit to entry-level Quality Assurance professionals and others who audit QC Labs, or whose responsibilities include insuring lab regulatory compliance. This course will provide participants with an understanding of how to effectively handle out-of-specification results, deviations, laborator...

Healthcare in the United States is facing an ever increasing crisis directly effecting patient care – wide spread and lengthy shortages of essential drugs needed to provide good quality care. This global problem is complex and stems from economic, legal, regulatory, policy, and clinical factors that are deeply interconnected.Medical product shortages are harmful to all patients involved. There is no single or simple solution that can resolve this complex problem. Efforts to address this prob...

This course will be of benefit to pharma, medical device, and biotech professionals who manage documents for all therapeutic product development and marketing activities (including pre-clinical, clinical, QA, and regulatory functions). This two-day course is also valuable for QA auditors who need to understand what constitutes sound documentation and documentation management. Upon completion of this course participants will be able to increase your ability to implement efficient practices tha...

Upon completion of this activity, you will be able to: * list the communicable diseases and define the regulatory authority under which allogeneic blood donations must be tested. * list the communicable diseases and define the regulatory authority under which autologous blood donations must be tested. * define the risk versus benefit of storing and transfusing autologous blood that is known to be reactive/confirmed positive for a communicable disease test. * define the risk versus...

This two-day course is designed to give participants of all levels a strong foundation in the fundamentals of FDA regulatory compliance for drugs and biotech products. Additionally, this course will detail how to meet compliance objectives in a cost-contained manner. Upon completion of the course attendees will understand the guidelines, philosophy and practical approach to FDA compliance. Participants will have a firm grasp of the seven key strategies to cost-effective compliance, includ...

As coders we strive to have a solid understanding of the "rules" handed down by the payers and government. But, they are not all the same. During this audio conference we will address what rules are needed for proper claim submission along with where to find those rules. We will discuss how the rules can vary for services and payers. We will also talk about issues as they relate to the global surgical package, what it includes and what we can code outside of the package. We will take a good lo...

As a profession we are called to higher levels of safety and quality by government and professional organizations, by hospital administration, and most importantly, by patients to implement evidence based nursing care strategies to reduce error. Are you ready to assume ownership of basic nursing care activities with sufficient evidence to impact patient outcomes? This session will provide an in-depth look at evidence based fundamental nursing care practices to reduce or eliminate catheter as...

This two-day course is designed for all scientists (managerial and laboratory), regulatory affairs and compliance personnel who are active in pre-clinical studies and in other laboratory settings. The course will be of most benefit to professionals whose job function necessitates the generation, evaluation, assurance and submission of data from pre-clinical studies. By the end of the course, attendees will have a strong understanding of the fundamental compliance requirements for current Good...

October 24, 2011, The Centers for Medicare and Medicaid Services (CMS) published proposed changes for hospitals. These would affect any hospital that accepts Medicare or Medicaid which are most hospitals in America. This is one of the major revisions in more than two decades. These were written to comply with the President’s mandate to reduce the regulatory burden placed on hospitals. Interesting to note a consideration in reduction of the hospital conditions of participation in the past yea...

The purpose of this presentation is to provide pharmacists with practical and timely information to support the assessment and management of patients with chronic pain who are treated with opioid therapy. Dr. Scott Strassels, a pharmacist who specializes in the treatment of patients with chronic pain, answers questions and discusses the complexities involved with achieving balance between effective treatment of pain and reduction in prescription drug abuse. He offers professional health care c...

Field actions are a difficult yet necessary aspect of the medical device marketplace. The various stakeholders: regulatory agencies, physicians, users, patients, organizations and personnel are all affected but in different ways, having different requirements to be satisfied. Balancing these different requirements - some documented in regulation, others based on simple human need - creates challenges for those responsible for deciding and implementing field actions. Managing the impact of gl...

Healthcare facilities use vast amounts of energy, more than three times that of other commercial buildings. Yet many facilities don’t have an overarching strategy on measures to effectively reduce the cost associated with energy, but equally important is reducing the amount of energy consumed. While the market and other regulatory matters may limit the ability to affect the acquisition cost of the commodities of natural gas and electric, there are many steps that can be employed to conserve ...

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Innovation or Interference? The Future of Generic Ophthalmics in a Challenging Regulatory Environment: Off-Label Prescribing in Everyday Ophthalmology

Medical Peer Review: A Window on Quality Improvement

UTILIZATION MANAGEMENT PEER REVIEWER TRAINING

Comprehensive Overview of FDA Regulatory Compliance for Medical Devices

Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences

Pediatric Clinical Trial Design – Ethics, Management and Regulatory Requirements

Pharmaceutical Waste: Legal Updates, Responsibilities and Program Optimization

Latin America - Understanding Regulatory Compliance Requirements

CMC Regulatory Compliance for Biopharmaceuticals and Biologics

European Filing and Registration Procedures

The New ‘Standard of Care’ for IT Security: Shedding Light on the Black Hole

HIPAA Security Basics for the Pharmacy Workforce

Employment Law Update: A Focus on Compliance Issues for 2011

Isocyanates and Health: Past, Present and Future

Focus on Influenza

Infection Control 1409

Biosimilars – Understanding the Regulatory Challenges

Section 111: Liability and Compliance

Pharmaceutical, Biopharmaceutical, and Biologics Quality Control Laboratories: A Regulatory Compliance Primer

Procurement Strategies for Coping with Drug Shortages – a USP Approach

Effective Document Management for the Pharmaceutical, Biotech and Medical Device Industries

Communicable Disease Testing of Blood Donors

Comprehensive Overview of FDA Regulatory Compliance for Drugs and Biotech Products

apitalize on Unique Private Payer Rules

Back to the Basics: Getting There with Evidence on Prevention of CA-UTI’s

Good Laboratory Practices for Pre-Clinical Testing

CMS CoPs Proposed Changes for Hospitals in 2012

Assessing Benefits and Risks of Chronic Opioid Therapy – How Can Pharmacists Balance Pain Management with the Risk of Misuse?

Medical Devices – Field Actions and Their Management - Recalls, Product Recovery, Safety Alert

Strategic Energy Management & Conservation: Tips and Tools to Reduce Energy Costs and Consumption

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