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Instructor : Sarah Fowler-Dixon
Product Id : 20191PACK

Overview: Drug and device research is confusing and difficult on its own but when you start combining drugs with devices the regulatory landscape changes as there are more nuances to deal with. Knowing how drug and device studies are each regulated is important in navigating the challenges posed by studies that wish to use both. It is also important to be aware of current guidance affecting the use of both drugs and devices in a study as well current guidance affecting the classification of devices.

Why should you attend: Information on drugs and devices is plentiful. But, it can also be daunting .The webinar will give attendees a foundation and a starting point on which they can build. Learning objectives:
  • Define drug research
  • Define device research
  • Explore the differences between the two
  • Describe requirements when drugs and devices are combined in one study

Areas Covered in the Session:
  • Defining Drug Research
    • FDA approved drugs
    • Investigational drugs
    • Compassionate use
  • Defining Device Research
    • FDA approved devices
    • 510 K devices
    • Humanitarian Device Exemptions
    • Invitro Diagnostic Devices
    • Investigational Devices
  • Federal regulations governing drugs and devices
  • Guidance governing drugs and devices
  • Combining devices and drugs into one study
    • What are the requirements?
    • What are the regulations and guidance?
  • How these studies are reviewed

Who Will Benefit:
  • Investigators
  • Researchers
  • Research Staff
  • Study Coordinators
  • Auditors
  • Research Administrators
Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities.

She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she lead a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook.

Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.
Instructor : Sarah Fowler-Dixon
Product Id : 20191PACK

Overview: The Sunshine Act, or Open Payments Program, requires manufacturers of drugs, medical devices, and biologics that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. This Act was part of a healthcare reform bill adopted in March 2010. It came about due to requests for increased transparency about the financial relationships between physicians and industry.

The Centers for Medicare and Medicaid (CMS) issued the final rules in 2013 which implemented the Sunshine Act.

Why should you Attend: Anyone required to adhere to the Sunshine Act standards or anyone interested in knowing what must be reported and made public.

Areas Covered in the Session:
  • Purpose of the Sunshine Act
  • Who is required to report under the Sunshine Act?
  • What is reported?
  • Exclusions
  • Tracking
  • Penalties
  • Useful links

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

  • Human Subjects Research
  • Healthcare interested in exploring the field of Clinical Research
  • Clinical Research Coordinators
  • Principal Investigators/Physicians
  • Administration in charge of Clinical Research
  • Regulatory Compliance

Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities.

She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she lead a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook.

Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.
Instructor : Nagina Parmar
Product Id : 20191PACK

Overview: In order to become a safe and effective medicine, a compound has to travel through a lengthy process of rigorous testing. Over the last few decades, the amount of time required to develop and test a novel drug has increased drastically. However, the introduction of social media and digital technology into drug development have the ability to significantly expedite this process. This webinar will explore the policies and principles of using social media through the evolution of developing a pharmaceutical drug from its initial stages to its introduction into the market. This includes analyzing the methods in which pharmaceutical companies utilize social media during the planning process, identifying the best candidate for the lead compound in a drug, conducting animal and human testing, recruiting candidates for clinical trials.

The course will also be examining the manner in which pharmaceutical companies use social media for marketing and licensing purposes.

Why should you Attend: Social media has a huge impact on the pharmaceutical industries especially bringing drugs to the market safe and effective manner and reducing the overall time required for the development and approval of the drug. This webinar will explore the policies and principles of using social media through the evolution of developing a pharmaceutical drug from its initial stages to its introduction into the market.

Areas Covered in the Session:

Analyzing the methods in which pharmaceutical companies utilize social media during - the planning process
  • Identifying the best candidate for the lead compound in a drug, conducting animal and human testing,
  • Recruiting candidates for clinical trials.


Who Will Benefit:
  • Clinical Trials Sponsors (Pharmaceutical and Academic institutions)
  • Investigators
  • Study coordinators
  • Research Nurse coordinators
  • Principle Investigators
  • Senior Clinical Research Associates(CRAs)
  • Clinical Research Project Manager
  • Contract Research Organizations (CROs)
  • Site Management Organizations (SMOs)
Dr. Nagina Parmar has years of clinical research experience as a certified clinical research professional in academia and hospital. Her expertise as clinical research professional lies in coordinating various Phase I, II and III national and international clinical trials and investigator initiated trials. During her career as CCRP, she was also involved in developing SOPs (Standard operating Procedures), REB SOPs and research elements database. She is an active member of the Society of Clinical Research Associates (SoCRA) and Network of Networks(N2N). As an Adjunct faculty, Dr. Parmar is also involved in teaching Biology, Microbiology, Life Sciences for Clinical practice, and drug development courses at various academic institutions. Her writing appeared in more than 30 journal articles, books and reviews in various national and international journals.

As a mentor, Dr. Parmar has provided references and letter of recommendations to assist students with their endeavors. Dr. Parmar has given various career development seminars at University of Toronto to graduates and postgraduates and webinar with Association of Clinical Research Professionals (ACRP).
Instructor : Sarah Fowler-Dixon
Product Id : 20191PACK

Overview: Investigational device accountability is outlined in the FDA's regulations. Included in this topic is the receipt, storage, distribution, reconciliation, return and authorized destruction of investigational devices. Many industry sponsors already have standard operating procedures outline these policies but there are instances when a standard operating procedure or guideline does not already exist and those working with these devices need to know their responsibilities.

Learning objectives:
  • Define investigational devices
  • Review the regulations and guidance
  • Discuss device accountability requirements
  • Examine sample materials

Why should you attend: Investigational device accountability ensures that the investigational (non-FDA approved) devices are used only as described in IRB approved protocols under the direction and management of appropriately qualified research team members.

Areas Covered in the Session:
  • Investigator Responsibility
  • Applicable regulations and guidance
  • Definition of Accountability
  • Investigational device ordering and receipt
  • Investigational device storage
  • Investigational device requisition and use
  • Investigational device disposition

Who Will Benefit:
  • Investigators
  • Researchers
  • Research Staff
  • Study Coordinators
  • Auditors
  • Research Administrators
Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities.

She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she lead a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook.

Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.
Instructor : Sarah Fowler-Dixon
Product Id : 20191PACK

Overview: FDA 7348.811 section 1 states, "Regardless of the type of system used by the clinical site, the regulatory requirements for clinical data do not change whether clinical data are captured on paper, electronically, or using a hybrid system." What type of system is best for your program and investigator capabilities? The wrong choice yields inspectional non compliance.

The right choice of electronic data capture, direct data entry, and data management depends on a sponsor assessment of the systems and procedures at the investigator site as compliant with FDA inspectional requirements. Additional source documentation procedures (origination, authorization, and signature) are required at the investigator site to address the electronic data capture process. It is these three FDA mandated inspectional criteria, applicable to every electronic data element, that generate most of the significant inspectional noncompliant findings. Some data elements are more likely to be associated with the findings of noncompliance than others. It is in fact difficult to determine which data requires or does not require original source documentation and what defines "original source documentation".

Why should you attend: Investigators commonly assume that the new guidance and regulations reduce the need for source documentation in clinical trials. In fact, there are new procedural documents relevant to the electronic source documents and direct data entry that are required to comply with the current inspectional standards and the final guidance. Sponsor due diligence in choosing, training, and monitoring investigator sites to enable the use of compliant electronic data capture is required.

Basic knowledge of part 11 and GCP requirements will be helpful in attending this advanced webinar. The focus will be on the additional FDA inspectional requirements for electronic data capture, and the impact of using electronic data capture on the seven FDA inspectional priority objectives.

Areas Covered in the Session:
  • FDA definitions for data elements
  • FDA definitions of source data and types of electronic source data systems
  • The requirement for original source data to support every data element
  • The requirements for electronic data-origination, authorization, signatures and data tracking
  • What types of electronic data elements pose noncompliance challenges
  • Preventing non compliance by sponsor due diligence at investigator site
  • Participant input and questions

Who Will Benefit:
  • Clinical Research Coordinators and Investigators
  • Medical Record Personnel
  • Clinical CRA Monitors
  • Clinical Program Managers
  • Clinical Quality Assurance Auditors
Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities.

She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she lead a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook.

Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.