Chapter 1
- Biotech Startup Revolution
- Early-Stage Biotech Companies: Strategies for Survival and Growth
- Strategic Planning
- Biomedical Business and Legal Management Essentials
- FDA Year in Review: A Shifting Regulatory Landscape
- Development & Approval Process | Drugs
- Advanced Manufacturing
- Emerging Technology Program
- The Interplay Between the FDA Regulatory Process
- for Medical Devices and Patent Law
- The Interplay Between the FDA Regulatory Process for
- Medical Devices and Patent Law –
- Considerations for 510(k) Submission
- Cardio-Matrex : The New Paradigm
- Cardio-Matrex Tissue Engineering Biologics
- Regulatory Considerations in Manufacturing,
- Product Testing, and Preclinical Development of Cellular Products
Chapter 2
- Biopharma is a fast-growing world where
- big ideas come along daily
- Cellular & Gene Therapy Products
- A Tough Road: Cost To Develop
- One New Drug Is $2.6 Billion
- 12 Big Pharma Stats That Will Blow You Away
- Working together for safe medicines in the EU
- FDA New Right to Try
- FDA to end program that hid millions of reports on faulty medical devices
- Novartis $2 million gene therapy for rare
- disorder is world's most expensive drug
- Under Fire, Biopharma Increases Lobbying
- Expenses to Influence Opinion and Legislation
Chapter 3
- FDA’s New Safety and Performance Based Pathway
- How to Prepare an Abbreviated 510(k)
- Device Advice: Investigational Device Exemption
- The European Union: The Promised “CE Land”?
- No Risk, No Fun
- Possible Pitfalls of Cooperation with a Distributor
- To Register a New Product or Manufacture a New Drug the Following Country Regulatory Links are Provided
- China SFDA
- Hong Kong MDCO & PSDH
- India CDSCO
- Japan MHLW
- Korea KFDA
- Malaysia MOH
- Philippines DOH
- Taiwan TFDA
- Thailand FDA
- Vietnam MOH
Chapter 4
- What Happens During NDA Review In
- The FDA Drug Approval Process
- What Are the Major Regulatory Differences for Getting
- a Biologic Product Versus a Drug Compound into The Marketplace?
- Common Problems to Avoid with IND
- One-Third Of New Drugs Had Safety
- Problems After FDA Approval
- Chemistry, Manufacture and Control
- Fundamentals of Regulatory Affairs –
- The Submission Dossier
- 5 Laws That Will Affect the Pharma Industry
- Digital pills, aka ‘ingestible sensors’, are at a crossroads
- Drug Supply Chain - Spinning the pharma
- traceability wheel
- Cortellis Regulatory Intelligence – Data Bases
- Change Management Process – Slide Share #1
- The Design Control Cycle – Slide Share #2
- Life Cycle Approach to Validation – Slide Share #3
- Primary Responsibilities for Specifications - Slide #4
- When Should Processes be Validated? Slide Share #5
Chapter 5
- Biosimilar Approval Process
- New Drug Application
- Medical Device Classification Guide – How To Determine Your Device Class
- How to Find the Applicable FDA Regulations For Your Medical Device
- Medical device Classification in Europe
- Determining Your Path To Market in Europe and Canada
- 7 FDA Pathways To Bring Your Medical
- Device To Market
- Determining Your Path to Market in Canada
- FDA 510 (k) Process- How To Get
- It Right The First Time?
- Chemistry Manufacturing and Controls (CMC) Guidance’s for Industry (GFIs)
- Understanding the latest FDA guidance on investigational new drugs for cell and gene therapy VI International Conference on Harmonisation
- Quality Assurance VS. Quality Control in the Medical Device Industry
- The Ultimate Guide to Design Controls For Medical Device Companies
Chapter 6
- Congratulations! You have an idea for a new medical device. Now What?
- FDA Issues Draft Guidance on Cannabis
- Disruptive Approaches To Accelerate Drug
- Discovery and Development (Part 1)
- Regulatory Affairs Professionals
- Final Thoughts
