This document summarizes FDA regulations for gene therapy, cell therapy, and stem cell products. It discusses:
1) How these "new biologics" are regulated under different FDA centers and parts depending on their characteristics and risks. Products are either regulated solely under section 361 of the PHS Act or under both 361 and 351.
2) Key aspects of the new 21 CFR Part 1271 regulations including establishment registration and listing, donor eligibility, good tissue practice standards, and inspection authorities.
3) Issues related to specific cell therapies like stem cells, gene therapy vectors, and manufacturing challenges. The paradigm of regional manufacturing facilities for patient-specific products is presented as an optimal model.
These slides discusses on cellular and gene therapy: the use of cells and genes to treat disease. These therapies can be effective on a wide range of previously untreated diseases, such as hematological, ocular, neurodegenerative diseases, and several types of cancers.
This presentation deals with stem cell therapy & new avenues in stem cell therapy. It also discusses latest advances such as treatment against baldness, multiple sclerosis, type 1 diabetes, spinal cord injury, demyelinating diseases, deafness, eye, Parkinson's disease. Also discusses about umbilical cord stem cells and finally clinical trials without patients (organs on chips).
Current Good Manufacturing Practices: Drug and Biologics Rachel Hamilton
ACI’s FDA Boot Camp has been designed to give products or patent litigators, as well as patent prosecutors, industry in-house counsel, and life sciences investment and securities experts, a strong working knowledge of core FDA competencies.
These slides discusses on cellular and gene therapy: the use of cells and genes to treat disease. These therapies can be effective on a wide range of previously untreated diseases, such as hematological, ocular, neurodegenerative diseases, and several types of cancers.
This presentation deals with stem cell therapy & new avenues in stem cell therapy. It also discusses latest advances such as treatment against baldness, multiple sclerosis, type 1 diabetes, spinal cord injury, demyelinating diseases, deafness, eye, Parkinson's disease. Also discusses about umbilical cord stem cells and finally clinical trials without patients (organs on chips).
Current Good Manufacturing Practices: Drug and Biologics Rachel Hamilton
ACI’s FDA Boot Camp has been designed to give products or patent litigators, as well as patent prosecutors, industry in-house counsel, and life sciences investment and securities experts, a strong working knowledge of core FDA competencies.
Intellectual Property Rights (IPRs) are legal rights that protect creations and/or inventions resulting from intellectual activity in the industrial, scientific, literary, or artistic fields. The most common IPRs include patents, copyrights, marks, and trade secrets and Regulatory affair is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics, and complementary medicines, and by the companies
Animal cell culture in Biopharmaceutical Industry in the Production of Therap...Shubham Chinchulkar
This presentation will help you to understand the basics of Animal cell culture along with its applicability in the diagnosis and treatment of cancer, and autoimmune diseases.
Overview of FDA Drug Manufacturing RequirementsMichael Swit
Presentation on FDA Regulation of Drug Manufacturing to the Introduction to Drug Law Course sponsored by the Food & Drug Law Institute (FDLI) on July 25, 2018 in San Francisco.
Equivalence approches for complex generics DIA 11 april 2019 Bhaswat Chakraborty
This is a workshop that i gave a few days ago on bioequivalence of complex generics like peptides, polymers, liposomes, colloids, ophthamic and topical produtcts.
Tissue Engineering is the reconstruction of cells to differential cell into the desired tissue or organ in an attempt to improve their structural functions.
Regenerative medicine is an aspect of tissue engineering that uses bioengineering principles to solve healthcare challenges using new innovative ideas, methods and mode of synthesis of different biomaterials construct.
Tissue Regenerative Medicine uses scaffolding development to guide cells into differentiating in to desired tissue or organ.
Scaffolding provides an extracellular matrix for the cells, this extracellular matrix serve and act as the guides for their proper differentiation. (Hynes R.O, 2009)
Other Emerging fields; Protein / Genetic / Clinical Engineering
Speaker: Anne Tomalin, BA, BSc, RAC (US, CAN & EU), President of CanReg Inc.
Topics Addressed
* Planning ahead to add credibility and value with your partners, investors and outside experts
* What is the landscape of various filings for a drug, a medical device or a diagnostic device?
* Developing a multi-disciplinary project team to manage your regulatory strategy:
o Different strategies for different products
o How to formulate a sound path to drug development decision-making
* What is needed for approval of a medical device
* The preclinical studies required for an IND filing
* The multiple components of the actual IND submission
* Management and communication between the teams assembling the IND
o When to outsource and bring in consultants
* Interacting with the regulatory authority
Download an audio file of this presentation at:
http://www.marsdd.com/bioent/jan15
Intellectual Property Rights (IPRs) are legal rights that protect creations and/or inventions resulting from intellectual activity in the industrial, scientific, literary, or artistic fields. The most common IPRs include patents, copyrights, marks, and trade secrets and Regulatory affair is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics, and complementary medicines, and by the companies
Animal cell culture in Biopharmaceutical Industry in the Production of Therap...Shubham Chinchulkar
This presentation will help you to understand the basics of Animal cell culture along with its applicability in the diagnosis and treatment of cancer, and autoimmune diseases.
Overview of FDA Drug Manufacturing RequirementsMichael Swit
Presentation on FDA Regulation of Drug Manufacturing to the Introduction to Drug Law Course sponsored by the Food & Drug Law Institute (FDLI) on July 25, 2018 in San Francisco.
Equivalence approches for complex generics DIA 11 april 2019 Bhaswat Chakraborty
This is a workshop that i gave a few days ago on bioequivalence of complex generics like peptides, polymers, liposomes, colloids, ophthamic and topical produtcts.
Tissue Engineering is the reconstruction of cells to differential cell into the desired tissue or organ in an attempt to improve their structural functions.
Regenerative medicine is an aspect of tissue engineering that uses bioengineering principles to solve healthcare challenges using new innovative ideas, methods and mode of synthesis of different biomaterials construct.
Tissue Regenerative Medicine uses scaffolding development to guide cells into differentiating in to desired tissue or organ.
Scaffolding provides an extracellular matrix for the cells, this extracellular matrix serve and act as the guides for their proper differentiation. (Hynes R.O, 2009)
Other Emerging fields; Protein / Genetic / Clinical Engineering
Speaker: Anne Tomalin, BA, BSc, RAC (US, CAN & EU), President of CanReg Inc.
Topics Addressed
* Planning ahead to add credibility and value with your partners, investors and outside experts
* What is the landscape of various filings for a drug, a medical device or a diagnostic device?
* Developing a multi-disciplinary project team to manage your regulatory strategy:
o Different strategies for different products
o How to formulate a sound path to drug development decision-making
* What is needed for approval of a medical device
* The preclinical studies required for an IND filing
* The multiple components of the actual IND submission
* Management and communication between the teams assembling the IND
o When to outsource and bring in consultants
* Interacting with the regulatory authority
Download an audio file of this presentation at:
http://www.marsdd.com/bioent/jan15
Imagine a situation when a cell starts producing enzymes required for metabolism and those required for cell death (apoptosis) at the same time. The cell will be in a confused state and will not know which function to perform first. The needs of the body keep changing with time and cell has to tune itself to perform the desired set of activities. Gene regulation helps a unicellular organism to adapt well to the environment.
Kim Solez Introduction to regenerative medicine Fall 2015Kim Solez ,
Dr. Kim Solez presents "Introduction to Regenerative Medicine" on September 10, 2015 in the Technology and Future of Medicine course LABMP 590 http://www.singularitycourse.com at the University of Alberta in Edmonton, Canada. Copyright (c) 2015, JustMachines Inc.
London & Partners MedCity Cell & Gene Therapy Report londonandpartners
The golden triangle & Japan, natural collaborators in cell and gene therapy. Discover Cambridge, London and Oxford’s thriving life sciences ecosystem and cell and gene therapy expertise. The golden triangle offers clinical trials capabilities, a diverse population and single healthcare system, all supported by a committed government. Collaborate with us and help develop the next generation of cell and gene therapy treatments.
Regenerative Medicine: Impact of Convergence on Drug, Device, and Biologics D...MaRS Discovery District
Speaker Dr. Annemarie Moseley, CEO of Aggregate Therapeutics (Palo Alto) explores how drug-device combination products are altering the medical practice from development to regulation to treatment.
Part of the MaRS Emerging Technologies Event Series. More information on the series can be found here:
http://www.marsdd.com/emergingtech/
Quorum Review IRB presented a live webinar in September 2014 covering the details of IRB review for medical device studies and their special considerations.
Digital Scholar Webinar: Clinicaltrials.gov Registration and Reporting DocumentsSC CTSI at USC and CHLA
This 60-minute webinar covers the basic requirements for registration and results reporting requirements in Clinicaltrials.gov. Tips and tricks will be provided, as well as the most common issues to avoid to ensure a smooth and efficient process for public posting and updates to clinical studies. Learning Objectives At the conclusion of this webinar, participants will be able to identify internal contacts and resources available to assist with their Clinicaltrials.gov registration or results reporting.
A guideline on medical devices designed internationally for harmonization.
As the site access is unavailable have managed the data for easy access of the details for the Regulatory affairs aspirants of Masters of Pharmacy
CDSCO Biologicals - Rules, Regulations, Guidelines and Standards for Regulato...Mohamed Fazil M
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA)
1st Semester - Regulations and Legislation for Biologics (MRA 104T)
Unit 2 - Rules, Regulations, Guidelines and Standards for Regulatory Filing of Biologicals
CDSCO Biologicals
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
34. FY 2006 HCT/P Inspections 354 Total 44.1 234 All other HCT/Ps 42.8 36 Cord blood stem cells Peripheral blood stem cells 45.7 87 Reproductive tissues Hours/ Inspection Number of Inspections Type of HCT/P establishment
55. WR Tolbert & Associates Consultants to the Biopharmaceutical Industry 11483 Cypress Woods Drive San Diego, CA 92131-3535 858-693-8163 wrt@wrtolbert.com / www.wrtolbert.com
