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October 4, 2017


Combination Products – Industry Challenges

7:30 AM - 5:30 PM Eastern

Combination products remain a compliance challenge for drug and device makers, diagnostics and biotech firms. The cross-industry nature of the combo products raises regulatory issues, manufacturing and marketing challenges.

October 5, 2017


6 Tips for Effective Quality Systems

1:30 PM - 2:30 PM Eastern

Quality is the defining characteristic for high-performing drug and medical device manufacturing businesses. These operations are, of course, compliant with applicable rules. But these organizations also think beyond compliance and focus on achieving and maintaining high quality systems. Fundamental to this shift is a manufacturer’s ability to provide regulators and executives with greater visibility into its operations and quality processes — processes that go beyond compliance and allow manufacturers to differentiate themselves in the market. Regulators recognize the importance of this concept and many of the new regulations and guidelines require that manufacturers make substantial changes to their quality systems, data management and submission processes.

October 5, 2017

Barnett International

Introduction to Clinical Research

9:30 AM - 11:00 AM Eastern

Have you ever wondered what clinical trials are and how they are conducted? This web seminar is designed to answer those basic questions. We will look at how drugs progress from discovery to testing in humans, and learn what it takes to obtain approval to treat a disease or condition. We will discuss the similarities and differences between drug and medical device development. Finally, we will review how Good Clinical Practice (GCP) is applied to clinical trials around the world and how it is designed to protect clinical trial participants and ensure that the information obtained during a clinical trial is accurate and reliable.

October 10, 2017

Barnett International

Writing Clinical Study Protocols

12:00 PM - 3:00 PM Eastern

The basis and success of any drug or device development program is the clinical trial protocol. Clinical trials conducted under an IND or IDE cannot begin without a protocol, and yet there is variability between companies and individuals on how to approach writing this critical document. Clinical trials and entire programs have failed because the protocol was not scientifically sound. Knowing how to effectively research and write a clinical trial protocol is essential to a compound achieving IRB and market approval.

October 12, 2017


Device Regulation Under Gottlieb & Trump

1:30 PM - 3:00 PM Eastern

In Part II of FDAnews’s Expert Insight Series, our panel dives deep into device regulation, policy and enforcement.

  • The FDA has issued a slew of new guidance documents aimed at medical devicemakers, also —
  • Comr. Gottlieb’s big-picture approach to device regulation has yet to emerge, as does —
  • What role patients will play in device development and approval, and —
  • How the FDA will sort out knotty issues surrounding combination products, and — most important of all —
  • How you will fare in the Gottlieb-Trump years.

October 16, 2017

Barnett International

Approaches to Address Challenges in Vendor Management

12:00 PM - 2:30 PM Eastern

Outsourcing in clinical development continues to grow and so do the challenges of ensuring quality outcomes. Managing a vendor vs. micro-managing a vendor will be discussed with some practices to improve the relationship. Recommendations for sponsor oversight practices are discussed with a review of helpful tools.

October 17, 2017

Barnett International

Current FDA and EMA Inspection Findings: Lessons Learned

1:00 PM - 2:30 PM Eastern

Failure to follow the investigational plan, inadequate Principal Investigator (PI) oversight, and informed consent irregularities remain high on the list of leading findings in U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) inspections. In this web seminar, we will examine real-world examples of some of the top 10 inspection findings from the Annual BIMO Inspection Metrics, and discuss appropriate corrective and preventive actions (CAPAs), equipping learners with solutions to avoid common pitfalls and ultimately avoid inspection findings in the future. Correct conduct according to GCP will be discussed and lessons learned applied to help prevent these findings from occurring again.

October 18, 2017

Barnett International

Developing Clinical Study Budgets for Sponsors

12:30 PM - 2:30 PM Eastern

In an environment where studies are becoming more challenging to execute and taking more resources and time than anticipated, it is key to develop a solid and flexible budget to allow for study execution challenges. In developing a budget it is critical to address all standard line items such as reimbursement for procedures, but how can the oversight and follow-up time be accurately calculated? How does Fair Market Value (FMV) criteria factor into budget development? What questions should be asked to determine additional, unwritten, study expectations? What are some key elements leading to delayed budget negotiation and approval? This web seminar will address the fundamentals of budget development and considerations for ensuring that budgets are developed fairly to ensure that sites are appropriately reimbursed for study expectations.

October 19, 2017


Making Sense of IVD Regulation: IVDs, LDTs, RUOs, IUOs, ASRs, or GPRs

1:30 PM - 3:00 PM Eastern

Devicemakers, IVD marketers and clinical labs struggle often with FDA regulation — and it’s no wonder. The rules governing IVDs are scattered throughout the CFRs , and exceptions, special cases and pitfalls abound. Some hapless firms have even followed the wrong set of rules — and endured 483s or warning letters as a result.

October 19, 2017

Barnett International

Building Relationships with Clinical Research Sites

11:00 AM - 12:30 PM Eastern

Relationships between sites and sponsors are often strained, and poor communication can interfere with having a productive study. Sites are contacted by multiple personnel during the study start-up process, and perhaps even during the study. By focusing on building relationships with the sites, the delays and errors in the startup and ongoing study process can be avoided. It is critical that the individuals working with the sites are in a position through training, knowledge, and support to positively reflect the sponsor and to ensure there is no gap in communication. This web seminar will focus on a variety of techniques for clinical study teams to use in building stronger relationships with the sites. Real-life scenarios and problem solving techniques will be discussed based on what can appear to be unreasonable monitor and sponsor requests to the site research staff.

October 24, 2017


How to Improve Your Clinical Trial Patient Recruitment: A Panel Discussion

12:00 – 1:00 pm Central Time

Recruiting study participants is arguably the most critical part of the clinical trial process. So, why is this important element of clinical research also one of the most difficult to execute?

During this interactive discussion on the challenges of patient recruitment, panelists, Beth Harper of Clinical Performance Partners and Kelly Anastasio of Yale University, will answer audience questions about some of the key reasons sites struggle with low enrollment.

During this presentation, you will:
  • Hear panelists’ experiences with study accrual
  • Learn new techniques for improved enrollment planning
  • Gain ideas for more effective patient recruitment advertising
  • Discover tools to ease the enrollment process

October 24, 2017

Barnett International

Preparation, Management, and Response to Inspections and Audits

10:00 AM - 2:00 PM Eastern

Faced with an impending audit or inspection, how do you prepare? If inspection results in findings, do you have the skills and tools to best respond to these issues to avoid further actions? This web seminar will provide an overview of what to expect and how to prepare for an audit or inspection. Real case scenarios in a workshop format will be used to help solve the dilemmas faced by both sites and industry when faced with discoveries from regulatory authorities or auditors.

October 25, 2017

Barnett International

Case Report Form Design, Strategy, and Standards

12:30 PM - 2:30 PM Eastern

The phrase “garbage in, garbage out” can be applied to the data collection efforts in clinical trials. To avoid this pitfall, it’s important to be thorough in the evaluation of the data collection items that will validate the protocol hypothesis endpoints and statistical analysis. It’s also important to consider the future compilation of data from multiple clinical trials for agency submission and the assurance that the data are in compatible format. With this goal in mind, it’s essential for data collection to be consistent, concise and compatible – hence the need for standards. CDISC and CDASH are instrumental in the establishment of these standards.

October 30, 2017

Barnett International

Good Clinical Practice: Practical Application and Implementation

9:30 AM - 11:30 AM Eastern

This web seminar provides an overview of the structural elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to how quality systems, or a lack thereof, impact overall data quality and regulatory risk. This web seminar is designed for professionals with at least two years of experience in the clinical research industry.

October 31, 2017

Barnett International

Preparing Clinical Research Sites for FDA Inspections

12:00 PM - 2:30 PM Eastern

This web seminar is designed for participants that are sponsors/CROs and research site representatives preparing for a research site FDA inspection. From audit readiness to action item resolution, each site faces its own unique challenges. This course will prepare you and your site for expectations from the FDA and provide concrete steps you can take to prepare before, during and after the inspection.


November 1-10, 2017

Barnett International

Advanced Good Clinical Practice: Practical Application and Implementation

8:30 AM - 12:15 PM Eastern

This course provides an advanced, in-depth review of the structural elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to how quality systems, or a lack thereof, impact overall data quality and regulatory risk. This program is designed for professionals with at least two years of experience in the clinical research industry.

November 7-9, 2017

Barnett International

Good Laboratory Practice for Non-Clinical Studies

1:00 PM - 3:00 PM Eastern

This web seminar will provide a general overview of the regulatory requirements for non-clinical studies conducted at both pre-clinical facilities as well as bio-analytical laboratories. The course is divided into two sessions: The first session will focus on general regulatory requirements from the facility and the organization’s perspective and the second session will focus on audits conducted per study. This web seminar provides training for the pre-clinical facility and the bio-analytical laboratory personnel as well as quality assurance staff on maintaining compliance to 21 CFR Part 58.

November 7-16, 2017

Barnett International

Conducting Clinical Trials Under ICH GCP E6

10:30 AM - 2:15 PM Eastern

This course provides a comprehensive review of Good Clinical Practice (GCP) and FDA regulations and requirements. Participants receive a foundation of knowledge about GCP, practical examples, and the underlying scientific and regulatory principles involved. Guidelines for each aspect of research are provided, as well as information on the structuring and preparation of protocols, consent forms, and investigator brochure. Information on maintaining an ongoing relationship with the FDA will also be discussed. This course enables clinical professionals to prepare concise documents and provide their company and the FDA with necessary information for the clinical studies.

November 16, 2017


Pharmaceutical Regulation Under Gottlieb-Trump

01:30 PM - 3:00 PM Eastern

In Part III of FDAnews’s Expert Insight Series, our panel takes up drug regulation, policy and enforcement.It will be 10 months into the Trump administration and the drug regulation picture will be coming clearer. New drug policies will have been established. New Trump-Gottlieb appointees will be assuming office. Many new products will have been approved. And it will be coming clear how fundamental standards for approval will differ from the past.

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