The document provides an overview of the stages involved in drug development from pre-clinical testing through clinical trials and regulatory approval. It outlines the various tests, studies and requirements at each stage, including in vitro and animal model screening, toxicity studies, pharmaceutical development, clinical trials in four phases, and post-marketing surveillance. It also describes the roles and requirements for different departments involved in clinical research.
Clinical research and its importance career in clinical researchRidhimaPatel2
This document is expressing the carrier opportunities in clinical research and how it important to learn clinical research for our society and the best institute providing absolute best training for the clinical research
A guide to become clinical research associatepptxRidhimaPatel2
An integral part of modules in clinical research courses focus on the ethical standards that have to be implemented without compromising the quality of trial results.
Regulatory Challenges to Successful Global Clinical StudiesMichael Swit
A review of key issues that can make or break the success of a clinical study conducted outside the United States, with an emphasis on site, GCP issues, challenges that vary nationally, and enforcement concerns.
Investigation Device Exemptions (IDEs) for Early Feasibility Medical Device C...BostonBiomedical
Marybeth Gamber, Senior Regulatory Affairs Principal in Consulting Services presented at the Opal Events Medical Devices Summit West on June 25, 2015 in San Jose, CA. The attached presentation entitled, “Investigation Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies,” will focused on the FDA Early Feasibility Study (EFS) program. The intention of the EFS program is for devices that are early in their development lifecycle for which preclinical test methods are either not available or adequate to provide information to advance the device development process. Ms. Gamber discussed the background of the IDE process, the creation of the EFS program and guidance, along with the key steps and considerations to consider when pursuing this path, including lessons learned from on early interactions with the FDA in this program.
Clinical research and its importance career in clinical researchRidhimaPatel2
This document is expressing the carrier opportunities in clinical research and how it important to learn clinical research for our society and the best institute providing absolute best training for the clinical research
A guide to become clinical research associatepptxRidhimaPatel2
An integral part of modules in clinical research courses focus on the ethical standards that have to be implemented without compromising the quality of trial results.
Regulatory Challenges to Successful Global Clinical StudiesMichael Swit
A review of key issues that can make or break the success of a clinical study conducted outside the United States, with an emphasis on site, GCP issues, challenges that vary nationally, and enforcement concerns.
Investigation Device Exemptions (IDEs) for Early Feasibility Medical Device C...BostonBiomedical
Marybeth Gamber, Senior Regulatory Affairs Principal in Consulting Services presented at the Opal Events Medical Devices Summit West on June 25, 2015 in San Jose, CA. The attached presentation entitled, “Investigation Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies,” will focused on the FDA Early Feasibility Study (EFS) program. The intention of the EFS program is for devices that are early in their development lifecycle for which preclinical test methods are either not available or adequate to provide information to advance the device development process. Ms. Gamber discussed the background of the IDE process, the creation of the EFS program and guidance, along with the key steps and considerations to consider when pursuing this path, including lessons learned from on early interactions with the FDA in this program.
Clinical trials that are needed for efficacy & safety evidence of Medical devices include feasibility (pilot) and Pivotal trials. An extended battery of preclinical trials are also needed for high risk devices.
Clinical Research Associate (CRA) - A Growing Career Path in Biotechnology / ...SOCRA CCRP Certification
SOCRA study guide - ES’ SOCRA CCRP Exam Study Guide – A resource to help those who is preparing for the SOCRA Certified Clinical Research Professional (CCRP) certification.
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Des...MedicReS
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Designs for Devices
Owen Faris, Ph.D.,Deputy Director, Division of Cardiovascular Devices, Office of Device Evaluation, CDRH, FDA
This presentation gives the details about career opportunities in clinical research, clinical research courses available in India and clinical research training.
Medical Device Clinical Studies and Protocol DesignMichael Swit
August 17, 2006 presentation to the IVT Medical Device Conference, focusing on the following relative to medical devices:
* Standards of Approval – What the Protocol Targets
* Key Considerations in Designing Clinical Studies
* Practical Lessons in Clinical Trial Design & Execution
Best Practices to Risk Based Data Integrity at Data Integrity Conference, Lon...Bhaswat Chakraborty
Data integrity can be implemented using several approaches. One of the most effective ways to implement DI is a risk based approach. The speaker elaborates this.
Clinical trials that are needed for efficacy & safety evidence of Medical devices include feasibility (pilot) and Pivotal trials. An extended battery of preclinical trials are also needed for high risk devices.
Clinical Research Associate (CRA) - A Growing Career Path in Biotechnology / ...SOCRA CCRP Certification
SOCRA study guide - ES’ SOCRA CCRP Exam Study Guide – A resource to help those who is preparing for the SOCRA Certified Clinical Research Professional (CCRP) certification.
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Des...MedicReS
FDA 2013 Clinical Investigator Training Course: Issues in Clinical Trials Designs for Devices
Owen Faris, Ph.D.,Deputy Director, Division of Cardiovascular Devices, Office of Device Evaluation, CDRH, FDA
This presentation gives the details about career opportunities in clinical research, clinical research courses available in India and clinical research training.
Medical Device Clinical Studies and Protocol DesignMichael Swit
August 17, 2006 presentation to the IVT Medical Device Conference, focusing on the following relative to medical devices:
* Standards of Approval – What the Protocol Targets
* Key Considerations in Designing Clinical Studies
* Practical Lessons in Clinical Trial Design & Execution
Best Practices to Risk Based Data Integrity at Data Integrity Conference, Lon...Bhaswat Chakraborty
Data integrity can be implemented using several approaches. One of the most effective ways to implement DI is a risk based approach. The speaker elaborates this.
Career Opportunities in the Clinical Research IndustryAccess-Pharma Jobs
Career Opportunites in Clinical Research, Regulatory Affairs, and Pharmacovigilance. International Clinical Research Academy and Access Clinical Research
Cell & Gene Therapy Clinical Development SolutionsCovance
Cell & Gene Therapy clinical development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Biotechnology consulting refers to the practice of organization involved in Pacificlinkconsulting services contact: San Diego, CA 92127 Phone: 858-335-1300
B. McLaughlin Associates, Inc. (BMA) has been a provider of customized, cost-effective clinical research support for over 18 years. Our services for drug, biologics, and device studies include Study Management, Regulatory and Financial Document Collection and Review, Regulatory Document Audits, Clinical Study Contract/Patient Budget Negotiation, Informed Consent Creation, Review and Change Management, Drug and Biologics Temperature Monitoring (Cold Chain), Data Management, and Clinical Scientist Support.
We recognize the importance of a successfully run clinical trial and have the industry experienced staff to enhance your study team and create positive results. Our Study Analysts, Data Analysts, and Study Managers will professionally run your projects to ensure timely completion of all contracted tasks, while keeping quality, accountability, and compliance paramount. Whether your outsourcing requirements are for the full life cycle of a clinical trial or just for a specific need, BMA is here to provide a flexible solution.
Our goal is to provide world class support services that keep your projects on time, within budget, and compliant to all regulatory authorities.
Cell & Gene Therapy Clinical Development SolutionsCovance
Cell & Gene Therapy clinical development solutions to reduce scientific, regulatory and commercial risks, and accelerate development wherever you are in your product's development.
Part of the MaRS Best Practices Series - Pre-Clinical development workshop
http://www.marsdd.com/bestpractices/
Speaker: James Ault, VP Regulatory Affairs, Ricerca BioSciences
Regulatory Compliance in Pharmaceutical DevelopmentGL.docxsodhi3
Regulatory Compliance in Pharmaceutical Development:
GLP & GMP
Jeffrey G. Sarver, Ph.D.
MBC 3100
March 8, 2016
email questions to:
[email protected]
*
Food and Drug Administration (FDA)Agency of U.S. Department of Health and Human Services (HHS)Protect public health and provide essential public servicesOther HHS agencies include: CDC, NIH, Medicare/MedicaidFDA responsible for assuring safety and efficacy of: Human Drugs - Center for Drug Evaluation and Research (CDER)Veterinary Drugs - Center for Veterinary Medicine (CVM)Biological Agents - Center for Biologic Evaluation and Research (CBER)Medical Devices - Center for Devices and Radiological Health (CDRH)Food/Supplements/Cosmetics - Center for Food Safety and Applied Nutrition (CFSAN)
Manufacture
Market Drug
NDA
FDA Review
Clinical
Trials
I, II, III
IND
FDA Review
Preclinical
Testing
Drug
Discovery
Drug Development/Approval ProcessIND – Investigational New Drug application (3-6 yr, $5M-$10M)FDA Approval → Proceed into Clinical Trials (~30% from preclinical tests)Clinical Hold → Collect More data or End DevelopmentNDA – New Drug Application (9-12 yr, $500M-$1B)FDA Approval → Drug Enters Market (~8% from preclinical tests)Not Approved → More Data or Adjust Application or End Development
Basic
Research
+
Target
Discovery
Preclinical Testing RequirementsMechanism of Action (in vitro) and Efficacy (in vivo)General Toxicology: Single and Repeated Dose (in vivo)Genotoxicity/Mutagenicity (in vitro/in vivo)Carcinogenicity (in vivo)Reproductive Toxicology/Teratology (in vivo)ADME (in vitro)/Pharmacokinetics (in vivo)Additional Safety TestingCore: Cardiovascular (hERG), Respiratory, CNSOther tests as needed based on structure, mechanism, general tox
Additional Information for INDChemistry, Manufacturing, and Controls (CMC)Structure, physical propertiesSynthetic method and scale-upPurity, identification of impuritiesDosage form/route, formulation, preparation, packagingClinical Study ProtocolsPrevious Human Experience (if available)
FDA Guidance Documents
Information on suggested: testing methods, analyzing and summarizing data
Can be found at: http://www.fda.gov/RegulatoryInformation/Guidances/Searching can be difficult/tedious, use appropriate filters:Product → Drugs (or Biologics)FDA Organization → CDER (or CBER)Document Type → Guidance DocumentsExample Guidance Documents available on Blackboard:Genotoxicity TestingCardiotoxicity (hERG) TestingChemistry, Manufacturing, and Controls (CMC) for Phase I DrugMaximum Safe Starting Dose for Clinical Testing
International Council on Harmonization (ICH)Harmonize procedures for evaluating/reporting safety, efficacy, CMC in multiple regions/countriesRegulators and industry representatives from participating regions collaborate to generate internationally acceptable guidelinesImprove efficiency of drug testing/reporting requirements for approval in multiple countriesOriginally Europe, Japan, U.S.Other countries adopting IC ...
Do you know how many rewarding job opportunities exist in the Clinical resea...Access-Pharma Jobs
If you are a BSc/MSc/PhD or MD/PharmD in career change, you can see some of the available career opportunities in the Clinical research industry and how to get in this field in this presentation made on Jan 14, 2017 at the Pharmacolloque 2017:
https://cra-school.com/news/
Similar to Careers In Clinical Research Industry Gp 06 Nov11 (20)
26. Synopsis Reg. approval pre-study inv. meet Idea Idea Final Protocol Final CRF Drug Supply Inv. & site selection Final Report Safety Monitoring Data processing & analysis Close-out Inv. Meet & EC approvals Site Initiation Monitoring Audits & inspection
27. Project Manager SPONSOR REGULATORY BODY Senior mgmt approval Study Monitor Investigator Central Laboratory Patients Labs / Services Data management & Biometrics Vendors CRA CRA CRA CRA Ethics Committee
57. … NOW PERCEIVED AS A GUINEA PIG SYNDROME ! Help !!! Help !!!
58. Pre-World War II Empiric Rx Evidence-Based Medicine Personalized Medicine Post-World War II … the future?
59. as much “ art ” as it is “ science ” much of evidence-based medicine is a “ gold-standard in treatment approaches”, keeping the "art" aspect in mind … is as good an approach as any to determining whether evidence-based medical study results are useful to you as you and your doctor consider possible treatment for whatever your medical problem is. “ Art” factor
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Editor's Notes
16 We take pride in our integrity as a company that improves people’s lives. We are devoted to maintaining top performance through teamwork . We value innovation in our products and leadershi p in our groups. We are committed to serving the communities around us. We are a corporation with a high respect for people and a sharp customer focus . These are our values at Pfizer.