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 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

FDAnews

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.

November 20, 2017

Barnett International

Risk-Based Site Monitoring

12:00 PM - 1:30 PM Eastern

In the current GCP regulatory climate, risk-based decision-making should be supported within the clinical Quality System. A management approach used in many industries where performance is critical under tight timelines for regulated activities, risk-based decision-making makes sense for such activities as sponsor monitoring in clinical research. Applying a risk-based approach to the monitoring and site management should be based on a given project’s risk profile. A risk- based approach can address current monitoring practices that are costly and ineffective, and help projects meet financial and compliance goals. This web seminar will present the concepts and case scenarios of risk-based monitoring (RBM).

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.