BayBioNEST’s First Annual Partnering Event will be held on April 24, 2007 from 12 p.m. to 5 p.m. at the Sheraton Palo Alto, 625 El Camino Real, Palo Alto, CA 94301. This high level partnering event will provide an opportunity for local companies to identify partners, build relationships, and evaluate technology.
The event USCD Extension: Introduction to Nanotechnology will be held on April 24, 2007 from 8 a.m. to 5 p.m. in Room 107, UCSD Extension Sorrento Mesa Center, 6925 Lusk Blvd., San Diego, CA.
The teleconference event Winning Product Subsmissions–Find Out What the FDA is Looking For and How to Get Your Product Approved Sooner will be held on Tuesday, April 24, 2007 from 11 a.m. to 12:30 p.m. PST. The audioconference will address the following:
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The importance and underlying principles of the FDA drug development process from Phase I through market approval;
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How to create adequate and appropriate FDA submissions throughout the drug development process covering CMC, Nonclinical and Clinical areas;
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What information about your new product should and should not be included in application packets;
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How to effectively prepare for, and communicate during, meetings with the FDA;
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The common pitfalls that lead to delays and non-approvable determinations ;
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How to maintain investor confidence throughout the review process;
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An overview of the different types of submissions from IND and IDE through marketing applications [NDAs, BLAs, PMAs, 510(k)s];
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Advice on how to communicate with the FDA during your development program and upon submission of your marketing application;
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Tips on the submission process — strategies for filing and how to avoid delays;
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The review process and related correspondence; and
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What’s new in compliance guidance documents.
Category:
Biotech Industry Events |
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The teleconference event Winning Product Subsmissions–Find Out What the FDA is Looking For and How to Get Your Product Approved Sooner will be held on Tuesday, April 24, 2007 from 11 a.m. to 12:30 p.m. PST. The audioconference will address the following:
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The importance and underlying principles of the FDA drug development process from Phase I through market approval;
-
How to create adequate and appropriate FDA submissions throughout the drug development process covering CMC, Nonclinical and Clinical areas;
-
What information about your new product should and should not be included in application packets;
-
How to effectively prepare for, and communicate during, meetings with the FDA;
-
The common pitfalls that lead to delays and non-approvable determinations ;
-
How to maintain investor confidence throughout the review process;
-
An overview of the different types of submissions from IND and IDE through marketing applications [NDAs, BLAs, PMAs, 510(k)s];
-
Advice on how to communicate with the FDA during your development program and upon submission of your marketing application;
-
Tips on the submission process — strategies for filing and how to avoid delays;
-
The review process and related correspondence; and
-
What’s new in compliance guidance documents.
Category:
Biotech Industry Events |
Comments Off on Winning Product Submissions – Find Out What the FDA Is Looking for & How to Get Your Product Approved Sooner
The event UC Berkeley Extension: The Drug Development Process will be held April 23-27, 2007 at the UC Berkeley Extension – Downtown Center, 425 Market Street, 8th Floor, San Francisco, California U.S.A. This four-day course will provide a thorough overview of all major activities involved in bringing a pharmaceutical therapy from discovery to market. Topics will include the following:
- pharmacology,
- metabolism and pharmacokinetics,
- toxicology, pharmaceutical development and production,
- clinical trials and statistical support,
- current regulations and the approval process,
- QA/QC compliance,
- intellectual property,
- commercial development planning and strategic marketing,
- program management,
- financing, and
- FDA perspective on industry inspections.
The LES TEchnology Transfer Seminar will be held April 23-24, 2007 in San Diego, CA.
The event GTCbio’s Enforcement & Litigation In the Biotech & Pharmaceutical Industry will be held April 19-20, 2007 in San Francisco, CA. The event will address: winning litigation strategies, minimizing product liability risks, controlling litigation costs, conducting successful internal investigation, and implementing anti-bribery compliance plans.
Category:
Biotech Industry Events |
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The event GTCbio’s Enforcement & Litigation In the Biotech & Pharmaceutical Industry will be held April 19-20, 2007 in San Francisco, CA. The event will address: winning litigation strategies, minimizing product liability risks, controlling litigation costs, conducting successful internal investigation, and implementing anti-bribery compliance plans.
Category:
Biotech Industry Events |
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The event Biotech Demystified: The Science Behind the Business will be held at the UC San Diego Rady School of Management in San Diego, CA on June 18th-21, 2007. The program is designed toprovide executives and decision makers with a practical understanding of the basic science behind the biotechnology and pharmaceutical industries. Topics will include:
- Science Fundamentals
- Cell and Molecular Biology
- Genetics
- Immunology
- Research Tools and Techniques
- Stem Cell Research
- Therapeutic Cloning
- Molecular Pharmacology
- Proteomics
- Cancer Biology: Targets and Therapies
- Pharmacogenomics and Personalized Medicine
- Neuroscience: Disease Targets and Therapies
- Drug Development Process: Discover, Development, Biomanufacturing
- Risk Management in Life Sciences
- Case Studies
- Lab Experiences.
The event Tunnel Consulting Summit – BioProcessing Throughout the Product Life Cycle will be held on Thursday, April 19, 2007 at Office Pavilion, 6920 Carroll Rd, San Diego, CA 92121from 8:00 a.m. to 4:30 p.m. The event will cover the following topics:
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Learn how to enhance process robustness and optimization;
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Develop a Quality by Design approach to biologics process development;
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Explore the benefits of PAT in bioprocessing;
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Gain insight into scale up of complex bioprocesses;
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Understand the importance of planning for workforce issues; and
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Achieve overall efficiencies and avoid potential pitfalls.
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Category:
Biotech Industry Events |
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