Marina Malikova
Marina Malikova
Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. 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 also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.
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 trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.
-
Trial Master File Requirements and Essential Regulatory Documents
Essential documentation serves to demonstrate the compliance of the investigators, Sponsors, monitors/CROs, and IRBs with the current regulatory requirements and ICH GCP standards. Techniques on how to develop best practices and meet all applicable regulatory requirements will be discussed.... -
4-Hour Virtual Seminar on Preparing and Submitting Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications, and Conducting FDA Meetings
A key role is played by what you submit to the regulatory agency, they hold more than just written applications. They also enclose systematic tracking, editing, publishing and strategy of crucial data. Through precise instructions, case studies and first... -
6-Hour Virtual Seminar on Introductory Pharmacology for Non-Clinical Professionals
This course is designed to introduce basic pharmacology concepts which are utilized in drug development and clinical research to non-clinical professionals. Topics will include the basic principles of pharmacology and overview of several major classes of therapeutic agents, with... -
Managing Phase I Clinical Trials
Managing clinical trials, of any size and complexity, requires strategic planning and efficient execution. In order to successfully deliver innovative therapies to patients with unmet medical needs the trial management guidelines need to be standardized further, and robust methods... -
Good Clinical Practices (GCP) Compliance – Audit Preparation and Inspection Readiness
This Good Clinical Practices (GCP) and auditing webinar will provide you with a working model on how to eradicate challenges related to clinical practice with emphasis on data quality and regulatory risk. This session will also help create proactive... -
4-Hour Virtual Seminar on Design and Conduct of Clinical Trials – Design Requirements, Statistical Issues, and Clinical Protocols
Clinical trials play a pivotal role in evidence-based medicine. This course will provide an introduction to the scientific, statistical, and ethical aspects of clinical research. Topics will include basic principles and current methodologies used in the design, implementation, and... -
Mitigate Fiscal Risks in Clinical Trials
This webinar will discuss good clinical practices, core principles, and project management strategies applicable to financial aspects of clinical research during new biomedical product development process. Strategies and best practices to mitigate fiscal risks in clinical trials will be... -
6-Hour Virtual Seminar on Good Clinical Data Management Practices
Clinical data management (CDM) is paramount for a successful research. After all, Garbage In, Garbage Out (GIGO). CDM involves all aspects of collecting, processing, and interpreting information. There are many types of computer applications and database systems to support... -
6-Hour Virtual Seminar on Project Management in Clinical Research
This course is an integrative learning experience, combining a comprehensive review of the good clinical practice core principles and project management strategies applicable to clinical research during the new drug development process. This course examines the concepts and applied... -
Building QbD and RBQM Systems into Clinical Operations
This session is focused on Quality by Design (QbD) and new regulatory requirements for Risk-Based monitoring and building Risk-Based Quality Management (RBQM) systems. Besides being a new expectation by regulatory agencies under good clinical practices, Quality by Design (QbD)... -
HIPAA Compliance Monitoring and Auditing
We’ll use real-world examples to help explain the Privacy Rule, which governs patient rights and disclosure of protected health information (PHI), We’ll explain what’s meant by covered entities (CE), business associates (BA), and many other relationships within the health... -
Risk Management in Clinical Research
The premise behind RBQM is that monitoring quality can be improved by leveraging existing data intelligence. This, in turn, calls for more robust quality assurance (QA) systems focused and efficient resource utilization and allocation at the clinical site level.... -
3-Hour Virtual Seminar on Safety Audits and Pharmacovigilance (PV) Inspections
The European Medicines Agency’s (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine... -
Sale!
-
Sale!
-
Essential Regulatory Documents and Regulatory Requirements for Biomedical Products
This session will cover the regulatory requirements for biomedical investigational products such as drugs, biologics, and devices. Intended for those interested in regulatory affairs or in the clinical evaluation, development, manufacture, testing and/or commercialization of these products. Provided is... -
Sale!
-
ICH GCP Guidelines E6 Revision, R2 Addendum – Changes Impacting Sponsors-CRO-Sites
The revised guidelines are entitled “Integrated Addendum To ICH E6(R1): Guideline For Good Clinical Practice E6(R2).” The ICH steering committee comprised of representatives from the pharmaceutical industry and the regulatory bodies of the United States, Japan, the European Union...
