Events

Conferences

November 12-15, 2017

MAGI’S CLINICAL RESEARCH CONFERENCE – 2017
West San Francisco, CA

A Meeting that Matters. Obtain practical tips and professional contacts that will pay for the conference in a matter of days. At the last MAGI conference, participants gathered an average of 10 practical tips to implement in their own organizations.

A Meeting that Matters. Obtain practical tips and professional contacts that will pay for the conference in a matter of days. At the last MAGI conference, participants gathered an average of 10 practical tips to implement in their own organizations.

  • 100+ sessions and workshops in six tracks: clinical operations & project management, site management, regulatory compliance, contracts, budgets & billing, and special topics.
  • Exceptional networking with a broad (but not too broad) range of experienced clinical research professionals
  • 22+ continuing education contact hours (CME, CNE, CLE, CCB and many others)

Featuring the MAGI Study Connection. Sponsor/CRO and site speed dating.

Networking. The conference is structured to facilitate networking and promote lasting relationships. About half of the attendees have leadership roles like CEO, vice president, or director. Over two-thirds have eight or more years of clinical research experience. Study sponsors and CROs (30% of participants) are split about 70% biopharma and 30% medical device. Sites (50% of participants) are almost evenly split between (a) academic medical centers, (b) health systems and community hospitals, and (c) independent sites and networks. Meet people from all sides of the table in an open, friendly and energetic environment.

Satisfaction Guarantee. MAGI is the only clinical research conference that offers a money-back satisfaction guarantee. Find out for yourself why 99% of participants are satisfied with MAGI conferences (100% at our last conference).

Register Today. Save $100 with CenterWatch discount code CW152. For details and registration, visit: https://www.magiworld.org/events/2017W/

November 27-29, 2017

Design of Medical Devices Conference, China 2017
Location: Beijing Int'l Convention Center

The premier event each year in the Medical Device space is the Design of Medical Devices conference held at the University of Minnesota each year, sponsored by the UMN Medical Devices Center. This conference has been operating for 16 years and draws experts from around the world. This year is the first year the event is being held in China, in Beijing on 27, 28, 29 November.

The first Design of Medical Devices Conference-China will be held at the Beijing International Convention Center. DMD China will have an innovation workshop, 2 days of full programing with sessions and keynotes along with tour events. One of the main focuses of this conference will be potentials of collaboration regarding medical device innovation, development, manufacturing and distribution.

Register online today.http://www.dmd.umn.edu/china/registration

December 5-6, 2017

Data Integrity: The Key to FDA and GMP Compliance
Arlington, VA

Workshop with 10 interactive sessions on data integrity requirements, accountability, critical elements, validation protocol, cutting costs, recordkeeping and much more.

For details and registration, visit: http://www.fdanews.com/fdadataintegrity

December 7-8, 2017

SOPs for the 21st Century: Why Less is More
Arlington, VA

Two day workshop that teaches the practical techniques needed for writing fast-read, flexible and compliant SOPs—SOPs that will meet FDA requirements.

For details and registration, visit: http://www.fdanews.com/sops

February 13-18th, 2018

SCOPE Summit for Clinical Ops Executives 2018
Orlando, FL

The 9th Annual SCOPE Summit, taking place February 13-15, 2018 in Orlando, FL, will offer three stimulating days of in-depth discussions in 18 different conferences, 3 plenary keynote sessions, and the ever-popular interactive breakout discussions focused on advances and innovative solutions in all aspects of clinical trial planning, management and operations: Site Selection and Management, Patient Engagement, Recruitment and Retention, Protocol Optimization, Feasibility, Data Strategy & Analytics, Sensors and Wearables, Project Management, Outsourcing, Forecasting, Resource Management and Capacity Planning, Budgeting and Contracting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, Observational Research, Clinical Supply Chain, and Precision Medicine.

For details and registration, .http://www.scopesummit.com

April 4-5, 2018

Let’s improve clinical trials today!
Gaylord National Resort and Conference Center, Maryland

Join industry leaders from pharma, biotech, clinical research organizations, health care organizations, and advocacy groups to advance patient and physician participation in clinical trials. The forum will discuss how we can bridge people and processes, technology and regulations. Become a sponsor!

Register Now.www.bridgingclinical.com

Training Programs

November 20-21, 2017

Clinical Project Management: Intermediate
San Diego, CA

The course builds on project management basics to examine some of the more difficult issues encountered by clinical project managers. It examines approaches for optimizing clinical trial conduct and includes discussion of current hot-button concerns facing clinical project managers.

Take advantage of our $1,675.00 price by registering early!* After October 18, costs are $1,875.00.

November 28-29, 2017

Auditing Techniques for Clinical Research Professionals
Philadelphia, PA

This workshop teaches practical, immediately usable techniques that top-notch Good Clinical Practice (GCP) auditors and FDA investigators employ. They include techniques that are useful when auditing clinical trials that employ Electronic Medical Records (EMR) and/or Electronic Data Capture (EDC). When monitors and auditors apply these techniques, they can better detect, correct, and prevent clinical study performance deficiencies at clinical sites and within their organizations. Significant updates to the seminar focus on the development and utilization of quality systems (QS) at clinical sites to improve their performance. The workshop will emphasize Simple Efficient & Effective QS processes that clinical site personnel can utilize and how monitors and auditors can help them develop and implement them.

Take advantage of our $1,675.00 price by registering early!* After October 27, costs are $1,875.00.

December 4-5, 2017

Advanced Good Clinical Practice: Practical Application and Implementation
Boston, MA

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.

December 4-6, 2017

CRA & CRC Beginner Program
Philadelphia, PA

This beginner course provides an excellent introduction to clinical research and the job responsibilities of Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs). It explores topics relevant to those considering a career as an entry-level CRA or CRC.

December 5-6, 2017

Drug Safety and Pharmacovigilance: Effective Drug Safety Reporting and Surveillance
Boston, MA

This course covers the fundamentals of drug safety and pharmacovigilance, including regulatory requirements, adverse event reporting, signaling and risk management. The course addresses the regulatory issues across US and EU agencies that improve safety, but slow down the product approval process. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence, and regulatory compliance. This course will provide learners with regulatory references, processes, best practices, and analysis and investigation techniques to minimize risk, avoid product recall, and meet US and EU safety reporting standards.

December 12-13, 2017

Clinical Project Management: Introduction to Practical Clinical Trial Planning for Project Managers
Philadelphia, PA

This course is an introduction to clinical project management in the pharmaceutical industry. The focus is on individuals who want to learn basic project management skills and how they can be applied to the drug development process, especially in the management of clinical trials. The needs of relatively new project managers who are not familiar, or experienced, with specific technical tasks involved in clinical trial management are addressed. There is specific focus on the need to anticipate, understand, and implement detailed project management activities in a proactive manner. This course includes discussion of a highly detailed and fully developed clinical trial management process map. Discussions of the process map are practically oriented with emphasis given to useful advice that, when implemented, will assist with trial management

December 12-14, 2017

Monitoring Clinical Drug Studies: Beginner
Boston, MA

This fundamental “how to” and “why” workshop focuses on current regulatory requirements to promote successful monitoring of studies. Participants will learn about the role and responsibilities of the monitor, the investigator, and the IRB from pre-study through post study. Best practice techniques for site management will be provided, and activities such as case scenarios and simulation exercises reviewing an informed consent document, investigator study file, subject case report forms, and source documents will reinforce learning concepts. This is a practical, hands-on introduction to the job and how clinical monitoring tasks are performed.

December 12-13, 2017

Preparing IND Submissions: How to Organize, Write, Submit, and Track Submissions
San Francisco, CA

The Regulatory Department is the key contact with regulatory agencies. Regulatory must prepare documents that inform the Agency about the proposed development plan, keep the Agency up to date and answer any questions the Agency has about an on-going investigation, request and prepare for meetings with the Agency to discuss development plans, construct and write the marketing application and submit any updates to the marketing application in a concise and informative manner.

December 19-20, 2017

Monitoring Clinical Drug Studies: Intermediate
Boston, MA

This course reflects current industry trends and challenges for the more experienced monitor/clinical research associate – with a focus on developing tools and identifying challenges for effective monitoring. Industry standards and best practices will be discussed with an emphasis on the relationship between the Sponsor/CRO and the Investigator/site personnel. References and resources (including those available online) will be provided. Topics include site management, developing tools for effective monitoring, comonitoring assessments, challenges in our global environment, and successful time management. Discussion will include how sponsors/CROs interpret and implement various aspects of clinical trials and GCP principles.

Take advantage of our $1,675.00 price by registering early!* After November 17, costs are $1,875.00.

January 23-24, 2018

Monitoring Clinical Drug Studies: Advanced
San Diego, CA

This course will focus on more complex and challenging issues affecting the Clinical Research Associate with management/leadership responsibilities. Current hot topics and trends will be discussed. Participants will analyze case studies to identify how monitors/study leaders could have identified, managed, and followed up on under performance or non- compliance issues. Corrective and preventive action plans (CAPA) will be developed as part of the course activities. Training and mentoring techniques will be included to assist training/mentoring sponsor/CRO and site staff.

January 24-25, 2018

Conducting Clinical Trials Under ICH GCP E6
San Diego, CA

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.

Webinars

November 21, 2017

Barnett International

Sponsor Management of Investigator Non-Compliance

12:00 PM - 2:00 PM Eastern

Investigator non-compliance to the Statement of Investigator commitments has increased in many areas. One of the identified causes has been monitoring. Investigator compliance issues are great risks to product development success, but an even greater risk to sponsors is the lack of formal systems to manage compliance at research sites.

November 22, 2017

Barnett International

CRO Partnership Management

12:00 PM - 2:00 PM Eastern

In an environment where we are outsourcing multiple tasks, it is valuable to understand the dynamics of relationship building and the application of practical management. Extensive knowledge and skill are required to manage large teams, especially when the majority of the team functions outside of your organization. This web seminar provides an overview of Contract Research Organization (CRO) partnership building, management, application of root cause analysis (RCA) and strategies for problem solving.

November 28, 2017

FDAnews

Challenges in Multi-Site Environmental Monitoring

11:00 AM - 12:00 PM Eastern

Centralizing a monitoring system on a single enterprise solution across multiple sites provides several benefits, primarily cost-savings and risk-mitigation. On the cost savings side, only one server (or set of servers) is required, with fewer licenses. Because only one server needs to be validated, implementation and administration costs are reduced. One system means single point-of-contact for technical support, which not only simplifies operations, it increases purchasing power with your system vendor. On the risk-mitigation side, a single-server set-up can be better protected in a corporate data center. Maintenance activities such as back-ups, disaster recovery, and change-controls also are easier to implement. Further, compliance risks are reduced with a controlled, centralized, and validated system. Of course, there can be downsides to enterprise-level systems and tradeoffs in every system implementation.

December 1, 2017

Barnett International

eTMF Quality Oversight: A Risk-Based Approach

1:00 PM - 3:00 PM Eastern

When applied to electronic Trial Master File (eTMF) oversight, risk-based management is the combination of the potential of quality issues occurring and the impact these deficiencies may have on the integrity of the TMF and the overall Good Clinical Practice (GCP) impact on the study. The TMF is comprised of many records and documents, and a quality TMF is defined as a collection of records, which is complete, collected in a timely manner and comprised of quality records.

December 4, 2017

Barnett International

Final ICH GCP E6 R2: Changes Impacting Sponsors/CROs

9:00 AM - 11:00 AM Eastern

ICH GCP E6 R2 is the first revision in 20 years and includes changes that are prescriptive, detailed and more consistent with the rapid, ongoing changes in the complexity and rising cost of clinical trials. Understanding these changes and how they impact your organization is the first critical step towards implementation. This web seminar will describe the addendums in a step-by-step process and provide a parallel discussion of how the revised guideline can improve efficient approaches to trial management.

December 5, 2017

Barnett International

Cases in Advanced GCP: A Problem-Solving Practicums

12:00 PM - 3:00 PM Eastern

This application-based web seminar covers advanced concepts and challenges encountered in the application of Good Clinical Practice (GCP). During this highly interactive course, participants will review and discuss cases that include GCP challenges in topic areas such as IRB/IEC approval, informed consent, drug accountability and reconciliation, SUSAR submissions, communications with ethics committees and health authorities, as well as the management of investigational product. Cases are based on actual industry examples, and participants are expected to solve cases by applying Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) principles, which are briefly reviewed.

December 6, 2017

Barnett International

Introduction to Data Management

12:30 PM - 2:30 PM Eastern

This web seminar provides an excellent introduction to clinical research data management, focusing on processes and their rationale, making it ideal for the new data manager and other individuals who wish to learn basic clinical data management functions.

December 7, 2017

Barnett International

Source Documentation: What is Adequate & Accurate?

9:30 AM - 11:30 AM Eastern

Lack of adequate and/or accurate source documentation has been noted as a common deficiency in inspection findings of Clinical Investigators. There is significant variability between stakeholder requirements regarding source documentation per study, including sponsor to sponsor, sponsor to site, etc. The creation and use of source document worksheets and the use of the Case Report Form (CRF) as the original source have raised a lot of industry debate. These issues and more regarding adequate and accurate source documentation to meet the requirements of regulatory agencies essential documentation standards will be presented and discussed.

December 8, 2017

Barnett International

Trial Master File (TMF) for Sponsors: Set Up and Maintenance

11:30 AM - 1:30 PM Eastern

The Trial Master File (TMF) is a collection of the essential documents for a sponsor to record how they have fulfilled their obligations as sponsor for a clinical trial project. This web seminar reviews the sponsor TMF required and additional content for a clinical trial. The activities of set-up, maintenance, and quality control and assurance will be discussed along with common deficiencies and challenges. This web seminar will also include handouts and discussion of the TMF Reference Model.

December 11, 2017

Barnett International

Investigator Initiated Trials: Roles and Responsibilities

9:30 AM - 11:30 AM Eastern

Investigator Initiated Trials (IITs), also referred to as Sponsor-Investigator (SI) Trials are increasing in popularity. A Sponsor-Investigator is anyone who functions as the Clinical Investigator (CI) of a given study and who also holds the investigational marketing application, i.e., the IND or IDE. How does the CI ensure compliance to both the investigator and sponsor responsibilities? This web seminar will present the responsibilities, discuss risk, and provide suggestions for compliance.

December 11, 2017

Barnett International

Monitoring Visit Reports for Medical Device Studies

1:00 PM - 2:30 PM Eastern

In this web seminar, we will discuss how to write effective monitoring visit reports for medical device studies. Participants will learn the purpose for monitoring investigational sites and the importance of documenting the visit. We will examine the requirements for the documentation in the Code of Federal Regulations and International Conference on Harmonization Guidelines, and discuss how the report is used by various stakeholders. Tools will be provided to enable learners to scrutinize various sections of the report to better document what was accomplished on the visit. This documentation supports the adequate monitoring obligation expected by regulatory authorities.

December 12, 2017

Barnett International

Monitoring Reports: 10 Rules of Effective Report Writing

8:30 AM - 11:30 AM Eastern

The Clinical Research Associate (CRA) creates reports that have many audiences, one being regulatory authorities reviewing essential documentation of clinical trials linked to marketing application approvals. This web seminar presents 10 categories of scientific report writing in the context of the role of the CRA and the reports that they write. The applicable reports are monitoring visit reports, e-mails, telephone reports, Memos to File, and more. The concepts of writing in a scientific voice versus first person, objective versus subjective, and many more are presented. This course is invaluable for the CRA, as well as the individual who critiques the various reports.

December 13, 2017

Barnett International

Introduction to Statistics for Non-Statisticians

12:00 PM - 3:00 PM Eastern

This web seminar is intended for clinical research professionals who have little or no background in statistics. In it, we will cover the basic statistical concepts needed to understand the roles statistics play in health research. The topics addressed include types of variables, levels of measurement, descriptive statistics, precision, confidence intervals, and an introduction to hypothesis testing. This web seminar is beneficial to all clinical research professionals involved in the design, monitoring, interpretation, and reporting of clinical trials. Emphasis will be placed on understanding statistical information and not on calculations or statistical formulae.

December 14, 2017

FDAnews

Global Regulation Under Gottlieb-Trump and a Look Ahead

1:30 p.m. - 3:00 p.m. EST

A year into the Trump administration, there’s a lot you know by now — and a lot more you still don’t ...Will Scott Gottlieb’s FDA push to modernize Hatch-Waxman rules on generic approvals? What is the extent of FDA “untapped authority” to increase Rx-vs.-generic competition? What about expedited ANDA review? The agency has not received ANDAs for some 10% of brand-name drugs with expiring patent and exclusivity protections. The four new draft guidances are the work of a tight-knit team of senior staffers hand-picked by Comr. Gottlieb. Which Gottlieb brain-trusters are calling the shots? Most important of all: Will you benefit from Gottlieb’s moves ... or vice versa?

December 14, 2017

Barnett International

Case Narrative Writing for Reporting Adverse Events

1:00 PM - 2:30 PM Eastern

A narrative is a short document that is required by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to briefly describe the events in the life of a patient. These narratives are required when a patient enrolled in a study, after taking the study medication or approved drugs (post-marketing), has discontinued the study because of an adverse event, had one or more serious adverse events, or died. FDA, EMA, and International Conference on Harmonization (ICH) guidance documents call for the submission of a study subject’s experience in narrative form for those who meet these specific criteria. This web seminar will provide a set of guidelines, instructions, and templates for the writing of clinical and post-marketing case narratives for reporting adverse events.

December 15, 2017

FDAnews

How to Build A World-Class Audit Team

1:30 p.m. - 3:00 p.m. EST

The secret? A super-strong internal audit team — one that spots the issues most often cited in warning letters and nips them in the bud. Not following SOPs. Data integrity and good documentation practices. Incomplete investigations. Ms. Schniepp, a QA expert and award-winning author with 35 years’ experience, walks you through the steps that counter such errors and teaches you: Elements of an effective audit program, including naming members who not only know SOPs, but know whether you’re really following them. Better utilizing internal audit observations to drive continual improvement and remediate shortcomings before it’s too late. Qualities of effective auditors and team leaders — and how to spot them. Good documentation practices — the best prevention against warning letters and other regulatory headaches

December 15, 2017

Barnett International

CAP and CLIA Requirements for Clinical Research Laboratories

1:00 PM - 3:00 PM Eastern

This web seminar will provide a general overview of the College of American Pathologists (CAP) and Clinical Laboratory Improvements Amendments (CLIA) requirements for laboratories that perform routine and non-routine testing of clinical samples for clinical trials. We will review the laboratory requirements for patient care and the requirements for clinical research. Similarities and difference of CAP requirements from ISO 15189 Medical Laboratories Requirements for Quality and Compliance, as applicable, will be discussed. This web seminar provides training for the auditor/inspector assessing clinical laboratories for compliance.

December 18, 2017

Barnett International

Good Clinical Practice (GCP) for Medical Devices: ICH GCP E6 and ISO 14155

9:30 AM - 11:00 AM Eastern

Both ICH GCP E6 Guideline and ISO 14155 address the elements of Good Clinical Practice in the design, conduct, recording, and reporting of human subject research. Although many sponsors of medical device studies use the ICH GCP E6 Guideline as an ethical and scientific quality standard, ISO is written specifically to protect the rights, safety, and well-being of human subjects, ensure the scientific conduct of the clinical investigation and the credibility of the results, define the responsibilities of the sponsor and Principal Investigator, and assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

December 19, 2017

Barnett International

Understanding the FDA/OHRP Joint Draft Guidance on Minutes of IRB Meetings

12:30 PM - 2:30 PM Eastern

Institutions and institutional review boards (IRBs) are responsible for oversight of human subject research under HHS and FDA regulations. As part of meeting this responsibility, IRBs must prepare and maintain adequate documentation of IRB activities, including minutes of IRB meetings. Unfortunately, IRBs have routinely been cited in OHRP Determination Letters and FDA Warning Letters for failing to prepare and maintain adequate minutes. In this web seminar, we will discuss the FDA and OHRP Joint Draft Guidance on Minutes of IRB Meetings recommendations and the responsibilities of institutions and IRBs in the preparation and maintenance of minutes of IRB meetings to ensure compliance with regulatory requirements.

December 20, 2017

Barnett International

Use of Electronic Health Record Data in Clinical Investigations

12:30 PM - 2:30 PM Eastern

The FDA recognizes Electronic Health Records (EHRs) as data originators and in many cases, source documentation, which therefore subjects them to inspection. In its draft guidance for the Use of Electronic Health Record Data in Clinical Trials, the FDA expands upon prior guidance and provides its recommendations on the use of EHRs as source, and also outlines the responsibilities for ensuring quality and integrity of EHR data. As such, EHRs should be able to be obtained from multiple sources, they should be shareable, interoperable, and accessible to authorized parties. This web seminar will address recommendations for the use of EHRs as source data in clinical trials.

January 8, 2018

Barnett International

Clinical Trials and the Sunshine Act: The Effect on the Clinical Research Industry

1:00 PM - 2:30 PM Eastern

In an effort to increase transparency, highlight potential conflicts of interest, and ultimately decrease healthcare costs, one element of the Patient Protection and Affordable Care Act (PPACA) – the Sunshine Act – requires disclosure of payments or transfer of value to physicians. These physicians can also be involved in clinical research as Investigators, in which case additional information is required to be reported. Released in February 2013, the final rule requires applicable manufacturers of covered drugs, devices, and biological supplies to gather and report information to be listed on the public website. This web seminar will address the requirements for reporting of information derived from clinical research as well as exceptions for reporting.

January 9, 2018

Barnett International

Risk-Based Auditing: Effective Compliance Strategies

12:30 PM - 2:30 PM Eastern

An audit is defined as a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, the sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). Auditing focuses on the systems that generate this data, whereas monitoring tends to focus primarily on the data. Risk-based approaches to auditing, such as focusing on the most critical data elements, are more likely to ensure subject protection and overall study quality, and will permit sponsors to focus their compliance efforts more effectively. This web seminar will provide an overview of risk-based auditing skills and techniques, and a review of recent GCP audit findings from Clinical Investigators (sites), sponsors, and Institutional Review Boards (IRBs).