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(TMF)- Trial Master File: FDA Expectations from Sponsors and Sites

Carolyn Troiano

Recorded Duration : 60 Minutes

Life Sciences > Clinical | Biotechnology | Laboratory

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated indust...

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Good Clinical Practices: Practical Applications and Implementation, Audit Preparation

Marina Malikova

Recorded Duration : 90 Minutes

Life Sciences > Clinical | Biotechnology | Laboratory

Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investiga...

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Sunshine Act Reporting – Clarification for Clinical Research

Danielle DeLucy

Recorded Duration : 75 Minutes

Life Sciences > Clinical | Biotechnology | Laboratory

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in o...

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Investigator Initiated Trials- What Are We Doing to Ensure Human Subject Protection?

Dr. Nagina Parmar

Recorded Duration : 60 Minutes

Life Sciences > Clinical | Biotechnology | Laboratory

Dr. Nagina Parmar has 15 years of clinical research experience as a certified clinicalresearch professional in academia and hospital. Her exper...

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Developing & Managing a Trial Master File for FDA-Regulated Clinical Testing

Carolyn Troiano

Recorded Duration : 90 Minutes

Life Sciences > Clinical | Biotechnology | Laboratory

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated indust...

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Auditing Laboratories Conducting Assays Supporting Biologics

Gwendolyn Wise-Blackman

Recorded Duration : 60 Minutes

Life Sciences > Clinical | Biotechnology | Laboratory

Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly ...

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Auditing Laboratories Conducting Assays Supporting Biologics

Gwendolyn Wise-Blackman

Recorded Duration : 60 Minutes

Life Sciences > Clinical | Biotechnology | Laboratory

Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly ...

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Understanding Sponsor's Responsibilities for an Active IND

Gowri Sukumar

Recorded Duration : 60 Minutes

Life Sciences > Clinical | Biotechnology | Laboratory

Gowri Sukumar is the Director, CMC and Regulatory Affairs for Iterion Therapeutics, Houston, TX. Unique to her experience is leading all the te...

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Risk Based Approaches for Clinical Trials

Recorded Duration : 60 Minutes

Life Sciences > Clinical | Biotechnology | Laboratory

Webinar

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Developing & Managing a Trial Master File for FDA-Regulated Clinical Testing

Carolyn Troiano

Recorded Duration : 90 Minutes

Life Sciences > Clinical | Biotechnology | Laboratory

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated indust...

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Risk Based Approaches for Clinical Trials

LIVE : August 02 , 2024 01:00 PM EDT

Clinical Process Improvement

Joy L. McElroy

LIVE : August 07 , 2024 01:00 PM EDT

(TMF)- Trial Master File: FDA Expectations from Sponsors and Sites

Carolyn Troiano

Recorded Duration : 60 Minutes

Good Clinical Practices: Practical Applications and Implementation, Audit Preparation

Marina Malikova

Recorded Duration : 90 Minutes

Sunshine Act Reporting – Clarification for Clinical Research

Danielle DeLucy

Recorded Duration : 75 Minutes

Investigator Initiated Trials- What Are We Doing to Ensure Human Subject Protection?

Dr. Nagina Parmar

Recorded Duration : 60 Minutes

Developing & Managing a Trial Master File for FDA-Regulated Clinical Testing

Carolyn Troiano

Recorded Duration : 90 Minutes

Auditing Laboratories Conducting Assays Supporting Biologics

Gwendolyn Wise-Blackman

Recorded Duration : 60 Minutes

Auditing Laboratories Conducting Assays Supporting Biologics

Gwendolyn Wise-Blackman

Recorded Duration : 60 Minutes

Understanding Sponsor's Responsibilities for an Active IND

Gowri Sukumar

Recorded Duration : 60 Minutes

Risk Based Approaches for Clinical Trials

Recorded Duration : 60 Minutes

Developing & Managing a Trial Master File for FDA-Regulated Clinical Testing

Carolyn Troiano

Recorded Duration : 90 Minutes

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