Medical Writing: study protocol, informed consent form (ICF), Investigators Brochure (IB), serious adverse events (SAE) reports.

Marina Malikova

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This webinar is an integrative learning experience, combining a comprehensive review of the good clinical practice and required elements for clinical study protocol, Investigator’s Brochure (IB), informed consent elements and adverse event narrative writing.

Why attendees  should register:

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 or was hard to implements at different clinical sites. Knowing how to effectively write a clinical trial protocol and informed consent form are crucial elements to achieving IRB and FDA/EMA approval.

Investigator’s Brochure (IB) must be reflective of current drug safety profile and updated with regards to new safety alerts. Serious adverse events reporting is essential to ensure subjects safety and must be done in connection with IB updates. This session will provide an overview for IB contents and review of serious adverse events reporting requirements, attribution categories selection (i.e. causality, expectedness, etc.) and essential components of narrative writing.

Description of the topic:

This session is focused on required and optional elements of clinical study protocol and informed consent form, contents of Investigator’s Brochure, and overview of serious adverse events reports and narrative writing

Areas Covered in the Webinar Session:

·         Describe the overall structure of a protocol and regulatory requirements

·         Describe the requirements for a protocol, including:

o   Establishing the indication(s), purpose, objectives and outcome measures

o   Understand the types of studies

o   Develop the protocol design (single blind, double blind, randomized, etc.)

o   Identify the hypothesis

o   Establish safety and efficacy outcomes and how they will be measured

o   Determine inclusion/exclusion criteria

o   Determine the Schedule of Events

o   Determine safety assessments

  •   Review required and optional elements of informed consent, criteria for language and       comprehension by research subjects
  •   Review of serious adverse event reporting requirements and narrative writing  

Who will benefit: 

·         Medical Directors

·         Medical Writers

·         Clinical Research Associates

·         Regulatory Affairs Professionals

·         Research and Development Personnel

·         Project Team Leaders with limited direct clinical trial experience who will be managing drug development programs and supervising project managers

·         Grant Administrators

Target  Audience to market:

  • Medical Directors
  • Medical Writers
  • Clinical Research Associates
  • Regulatory Affairs Professionals

Research and Development Personnel

Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Marina Malikova, Executive Director, Surgical Translational Research

Dr. Malikova has over 15 years of experience in the clinical research field.  She has managed Phase I – IV studies involving investigational drugs, devices, biologics and combination products.  She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.

Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She has a strong background in biomedical sciences and has completed her postdoctoral fellowship in the field of cell signaling and cell migration.  She also holds a Master’s Degree in Clinical Investigation, Certification in Project Management from Boston University and dual board certified in Regulatory Affairs (RAC) for pharmaceutical products and medical devices by Regulatory Affairs Professionals Society (RAPS).

She also holds professional certification in Clinical Safety and Pharmacovigilance by Drug Information Association (DIA).

In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center.  She is responsible for clinical research operations, financial management, quality assurance, risk management, strategic planning, compliance assurance and macro-management of research programs. 

Dr. Malikova has 12 years of teaching experience as an Instructor for Clinical and Biomedical Sciences Program, Metropolitan College. She has developed and taught several courses such as: Design and Conduct of Clinical Trials, Drug Development, Introductory Pharmacology, Clinical Trials Management at Boston University, School of Medicine.

She also served as an Instructor of the Good Clinical Practices (GCPs) course for the Master of Science Program in Clinical Investigation, Division of Graduate Medical Sciences, Boston University, School of Medicine.

Dr. Malikova is a member of Association for Clinical Research Professionals (ACRP), Drug Information Association (DIA), Regulatory Affairs Professionals Society (RAPS) and European Society of Radiology (ESR).

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