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FDA CDER Small Business and Industry Assistance (SBIA)
FDA CDER Small Business and Industry Assistance (SBIA)
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Medical Affairs *
Scientific Communications Development
Strategic Stakeholder Engagement
Defining the Value of Medical Affairs
Evidence Generation
Strategic Communications Planning
Regulatory *
Labeling & Promotions
Maintenance & Renewals
Compliance
Transparency & Disclosure
Commercialization *
Customer Engagement
Brand Planning & Activation
Market Access & Policy *
Government Policy
Global Market Access
Pharmacovigilance *
Safety Systems
Risk Management
Finance & Investment *
Financial Services
Investment Banking
Quality & Mfg *
Facilities & Equipment
Testing & Release
Quality Management
Production & Supply Chain
Clinical Research *
Real World Data Research
Study Operations & Management
Clinical Reporting
Product Development
Trial Design & Planning
Technology & Operations *
Automation & Efficiency
Data & Analytics
Early Development
Digital Health Solutions
Operations
Informatics Infrastructure
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FDA CDER Small Business and Industry Assistance (SBIA)
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a Vice President
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a Senior Manager
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FDA Clinical Investigator Training Course (CITC) 2024 - Promo Video
The primary goal of this clinical investigator training course is to provide participants with the essential knowledge and skills to conduct clinical trials effectively, ethically, and in accordance with regulatory standards. The course aims to prepare clinical investigators to conduct high-quality research that contributes to scientific knowledge and improves patient care.
Participants will acquire a practical understanding of:
- FDA’s approach to trial design
- Statistical issues in the analysis of trial data
- Safety concerns in the development of medical products
- Understanding preclinical information relevant to medical product development
- Clinical investigator responsibilities
Register here ➡️ FDA Clinical Investigator Training Course (CITC) 2024 - 12/10/2024 | FDA
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Clinical Pharmacology Considerations for Novel Therapeutic Modalities - Webinar
This webinar will discuss the clinical pharmacology considerations for the development of novel therapeutic modalities. Our FDA subject matter experts will also address the unique considerations for oligonucleotide therapeutics and antibody-drug conjugates with respect to topics such as dose selection, exposure/response analysis, organ impairment, drug interactions, QTc assessment, and immunogenicity.
Register here ➡️ Clinical Pharmacology Considerations for Novel Therapeutic Modalities - 12/04/2024 | FDA
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M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final Guidance - Webinar
This webinar will provide an update and overview on the final M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms guideline including major changes from the draft guideline and FDA’s current bioequivalence (BE) guidance, delineate FDA’s planning on the implementation of M13A, and address questions and provide clarifications based on questions/comments received during public consultation of the draft guideline.
Register here ➡️ M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final Guidance - 11/21/2024 | FDA
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Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies - Webinar
This webinar will discuss the final guidance for the industry Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies which was published in July 2024.
Our FDA subject matter experts will also address recommendations from the guidance including, deciding whether and when to conduct the study, as well as how to design and report results from a human radiolabeled mass balance study.
Earn 1.0 CME/CPE/CNE!
Register here ➡️ Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies - 11/12/2024 | FDA
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Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation - Webinar
This webinar aims to inform stakeholders, particularly those who design, implement and assess risk evaluation and mitigation strategies (REMS), on the recently published guidance REMS Logic Model: A Framework to Link Program Design With Assessment.
This activity is intended to provide an overview of the REMS Logic Model, including its methodological underpinnings and proposed use.
Register here ➡️ Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation - 11/07/2024 | FDA
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FDA Clinical Investigator Training Course (CITC) 2024
The primary goal of this clinical investigator training course is to provide participants with the essential knowledge and skills to conduct clinical trials effectively, ethically, and in accordance with regulatory standards. The course aims to prepare clinical investigators to conduct high-quality research that contributes to scientific knowledge and improves patient care.
Register here ➡️ FDA Clinical Investigator Training Course (CITC) 2024 - 12/10/2024 | FDA
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