Online Essentials
The Online Essentials programs are webcasts designed to give you high level overviews of the topics listed below. These programs offer an insightful introduction for those who are new to the industry or want to cross-train in other areas of the life sciences. These programs are also a good introduction for the full day LifeScience Alley 101 programs. The webcasts are 35-60 minutes in length. Once your registration and payment are processed, you will receive login information, making the webcasts available for viewing at your convenience. Please note: it may take up to 1 business day to process your registration and receive the login information.
We encourage you to view these programs with a group of your peers or coworkers to facilitate topical discussion.
Pricing:
- Individual webcast = $59 (Members), $89 (Non-members)
- Package - All 3 = $129 (Members), $199 (Non-members)
Programs:
Essentials of Regulatory Affairs: Introduction to Device Regulation
Clinical Research Essentials: An Overview
Essentials of Research & Development in the Life Sciences Industry
Essentials of Regulatory Affairs: Introduction to Device Regulation
Speaker: Bob Klepinski, Officer, Fredrikson & Byron
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Topics included:
- Who are the people that regulate devices?
- A quick look at the law
- How do you get products on the market in the U.S.?
- What are clinical trials and how do you do one?
- Quality System Regulation (QSR)?
- European Union medical device regulation
- Advertising and promotion of medical devices
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Clinical Research Essentials: A One Hour Overview
Speaker: Sara Moeller, M.S., CEO, The Greenlight Group, LLC
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Topics included:
- The types of research trials
- Regulations about how to protect subject rights, safety and welfare
- FDA Regulations and guidance we follow in order to show that data is accurate and credible
- Get a deeper understanding of how noncompliance or mistakes can impact clinical trials, patient health and safety and the bottom line
- How to stay out of jail…
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Essentials of Research & Development in the Life Sciences Industry
Speaker: Rod Greder, President, New Productivity Group
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Topics included:
- Defining the process and framework for developing products in the life sciences – the planning, the stages and the key success factors
- Discuss external factors that affect New Product Development including the regulatory requirements and data management
- Examine the internal enablers that impact success including the organizational structure, roles and responsibilities
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