This medical device risk management webinar will discuss how to develop a Risk Management File in compliance with FDA and ISO 14971 requirements and what FDA will look for in risk evaluation and mitigation strategies (REMS) prior to or post approval of medical devices.

Why Should You Attend:

Manufacturers and Study Sponsors must understand the aspects of Risk Management, and how to effectively document their efforts. The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers or sponsors to ensure that the benefits of a product outweigh its risks. Regardless of whether FDA has made the request it always best to be proactive and have your risk management activities well documented.

In this webinar, we will discuss how Risk Management Files should be developed in accordance with ISO 14971 and what FDA is looking for in REMS. The presenter will explain how any product changes, including labeling, must be evaluated in accordance with your Risk Management procedures. You will also learn, from the presenter's first-hand experience, what the FDA expects during an audit of your risk management procedures.

Areas Covered in the Seminar:

• Overview of ISO 14971 Medical devices - Application of risk management to medical devices
• Discussion of key requirements
• What written procedures and training are required
• How to develop Risk Management Files
• How to apply Risk Management to Post-Approval Labeling Risk Management Strategy
• Understanding of what auditors expect

Overview: When disaster strikes, are you prepared? Sounds simple enough, but what does being prepared really mean? From a DR-BC perspective it means that you have all the elements in place to recover from a disaster, be it manmade or natural, and you have tested and validated that plan to ensure that it will work as designed. Failing to have a DR-BC plan could result in a finding of willful neglect, since having such a plan is a core requirement in the Security Rule and has been since early on.

Areas Covered in the Session:
The relevant requirements of the HIPAA Security Rule will be presented.
The requirements of the Disaster Recovery-Business Continuity Plan standard will be explained.
A framework creating a Disaster Recovery-Business Continuity Plan will be presented.
Identifying the elements of a comprehensive DR-BC plan will and how they fit together will be discussed.
An annual update process will be discussed to keep the plan up to date.
The importance of documenting actions taken in developing a DR-BC will discussed.

Who Will Benefit:
Security Officer
Information Systems Manager
HIPAA Officer
Chief Information Officer
Health Information Manager
Healthcare Counsel/lawyer
Office/Clinic Manager
Contracts Manager
Office and clinical staff
Business Associates
Compliance Director
CEO
CFO
Privacy Officer
Mark Sexton is an experienced information security professional who specializes in the fields of higher education and health care. In his role as the Manager of Information Systems with the University of Nevada School of Medicine, he managed complex technical programs at all levels of the organizational structure and provided staff and faculty with specialized information security training. He has over 16 years of information security teaching and leadership experience including physical security, operational risk management, compliance programs, and information security policy development. 

Overview: This webinar will discuss the Health Care Quality Improvement Act (HCQIA) in detail, including the standards that must be met to achieve immunity under the act. The HCQIA itself will be reviewed, including a detailed look at the Congressional purpose for the act. The legislative history of the act will be reviewed to gain an understanding of the intent of Congress in passing the act.

Specifically, there are four standards under the act that must be met. We will review each of these with an eye toward court interpretation of what actions an organization must take to achieve the protections granted by the act.
In the reasonable belief that the action was in the furtherance of quality health care
After a reasonable effort to obtain the facts of the matter
After adequate notice and hearing procedures are afforded to the physician involved or after such other procedures as are fair to the physician under the circumstances
In the reasonable belief that the action was warranted by the facts known after such reasonable effort to obtain facts and after meeting the [notice and hearing] requirement

Why should you attend: You should attend this webinar to gain an understanding of how the HCQIA protects your organization and those who participate in the peer review process in your organization, as well as gain an appreciation of the actions that are required to perfect the HCQIA immunity. Failure to take the appropriate actions and to follow the correct protocol can result in a disastrous situation.

Areas Covered in the Session:
The Health Care Quality Improvement Act
Legislative history of the Health Care Quality Improvement Act and the intent of Congress
Immunity under the Health Care Quality Improvement Act
Standards required to achieve immunity under the Health Care Quality Improvement Act
Review of the Health Care Quality Improvement Act by the courts

Who Will Benefit:
Chief Medical Officers
Hospital Administrators
Physicians
Quality Assurance Staff
Patient Safety Staff
Medical Staffs
William Mack Copeland MS, JD, PhD, LFACHE, practices health care law in Cincinnati at the firm of Copeland Law, LLC. He is also president of Executive & Managerial Development Group, a consulting entity providing compliance and other fraud and abuse related services. A graduate of Northern Kentucky University Salmon P. Chase College of Law, Bill is a frequent author and speaker on health law topics.  

This FDA warning letter closeout program will discuss how to successfully complete warning letter close out program which will help firm to obtain a closeout letter from FDA.

Why Should You Attend:

FDA Commissioner Margaret Hamburg recently announced several new enforcement initiatives. Part of the "new FDA" is the increased issuance of warning letters and the creation of a warning letter "closeout", which regulated firms can use to your advantage.
FDA's warning letter program has changed substantially and more warning letters will be issued - and faster! In the past, firms that received a warning letter from FDA were subject to unending scrutiny, speculation and financial challenge. But now warning letter recipients will have the chance to prove they are back in compliance. , FDA will provide a manner for a firm to demonstrate that it has complied with the terms of an enforcement action. The warning letter closeout program has begun as of September 2009. All firms who receive a warning letter will have the opportunity to obtain a "closeout" letter from FDA. Firms that fail to obtain a closeout letter will be clearly identified as still being under FDA scrutiny.

Attend this Webinar to know everything about warning letters, warning signs, issuance, company’s response and how to rectify the FDA warning letter close out mistakes.

Areas Covered in the seminar:

• Outline of FDA enforcement and compliance scheme.
• FDA inspection process.
• Lead up to a warning letter - warning signs.
• Warning letter issuance.
• Company response to FDA warning letters.
• What to avoid when dealing with FDA warning letters.
• Correcting FDA warning letter closeout mistakes.

Past experiences of FDA regarding 10-20 year life cycle changes of biologics has paved the way to entering into biosimilars – a new paradigm is emerging. In spite of the rich and varied European experience the FDA takes its own unique course. FDA advisory style meetings in a first step would determine eligibility of a new biosimilar candidate and for further meetings fees are charged as part of the new BsUFA . What genuine opportunities are there for harmonised US/EU and worldwide development? The selection of reference product dosage form and presentation has become more strategic than in the past years. Controversies towards regulatory clinical milestones need also to be crtically considered.

The presentation will cover the following areas:

• Interpreting the New FDA Rules and ‘Stepwise’ approach to demonstrating biosimilarity
• Consequential strategies for process development and manufacturing of biosimilars
• Comparisons of the European regulatory standards, with 6 years of approved use of biosimilars, and FDA requirements
• Opportunities and pathways towards harmonizing of FDA and EMA biosimilars development, including the choice of reference products 

This webinar will provide an in-depth understanding of anti-kick back and stark laws, and discuss how marketing activities can trigger either or both. It will show how to implement mandatory internal controls to reduce exposure to risks.

Why Should You Attend:

This webinar will provide the basic building blocks you will need to develop & maintain your company’s precious commodity – your reputation and eliminate exposure to fraud charges based upon marketing practices. It will also cover the practical requirements and operations, principles of compliance and the basic elements that every business has to have to reduce civil and criminal liabilities and economic sanctions.

After taking this webinar you will have an understanding of anti-kickback, stark, and compliance that shores up company weaknesses in marketing. You will know how to implement mandatory internal controls to reduce exposure to risks. Included is a case study discussion of how a company's marketing effort exposed the organization to many problems.

This session will benefit all functional groups who have data protection responsibility, marketing responsibilities, or need to understand the basics of compliance.

This clinical trial audit training will explain how to identify gaps and risks when preparing for regulatory inspections of sponsor monitoring programs by understanding the components of a clinical trial quality monitoring system.

Why Should You Attend:

In the current regulatory climate, sponsors should anticipate more FDA sponsor GCP inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site without relying on the “star performer.” Monitoring systems should include specific components to ensure control of investigational product, data integrity, oversight of vendors, as well as other areas. In this Webinar the components of a quality monitoring system will be presented so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections of sponsor monitoring programs.

Areas Covered in the Seminar:

• Discuss Sponsor monitors program.
• Identify components of a sponsor monitoring system: beyond SOPs.
• Distinguish each component’s suggested elements.
• Define adequate oversight of non-employee performers.
• Identify other measures to ensure quality monitoring.
• Evaluate gaps monitoring systems.