BioPharma Today

Trial Management Challenges at Academic Medical Centers: Why and How Can Sponsors Help?

Special $50 Off Savings! See the Registration section below.

Continuously increasing regulatory requirements, operational needs and financial pressures are forcing the Academic Medical Centers (AMCs) to re-evaluate and transform the way clinical research is managed. Many pharmaceutical and medical device companies are cutting back on their R&D budgets and industry has begun to look for new and hopefully less expensive sources of innovation. AMCs seem to be a perfect fit and they are quickly becoming a deal-making hot spot.

Establishing an Effective REMS Process: Significant Implications of Risk Management

Special Early Bird Savings! See the Registration section below.

Transforming the field of pharmaceutical risk management, the Food and Drug Administration Amendments Act of 2007 (FDAAA) granted the U.S. Food and Drug Administration (FDA) the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from a manufacturer to ensure that the benefits of a drug or biological product outweigh the risks.

Webinar: Breaking through the Fog: How NOT to Kill your Presentation with your Slides

Special $50 Off Savings! See the Registration section.

PowerPoint presentations have become a vital part of both internal and external communications at pharmaceutical and medical device companies. Whether you are from regulatory affairs, charged with presenting information on how to comply with new requirements to the manufacturing team or you are from a small medical device company presenting your product to possible investors, your presentation could mean the lifeblood of your organization. Not only do executives use presentation slides to make pitches to stakeholders, but doctors also use them to present information at meetings and conferences too.

Webinar: Trial Management Challenges at Academic Medical Centers: Why and How Can Sponsors Help?

Special $50 Off Savings! See the Registration section below.

Continuously increasing regulatory requirements, operational needs and financial pressures are forcing the Academic Medical Centers (AMCs) to re-evaluate and transform the way clinical research is managed. Many pharmaceutical and medical device companies are cutting back on their R&D budgets and industry has begun to look for new and hopefully less expensive sources of innovation. AMCs seem to be a perfect fit and they are quickly becoming a deal-making hot spot.

Complimentary Webinar: Outlook for the Biomedical Industry in 2012: What’s Affecting Innovation?

Join CHI-California Healthcare Institute and MERRILL DATASITE®, for a free, complimentary webinar where experts will review highlights from the January 9th J.P. Morgan Healthcare Conference.

Breaking through the Fog: How NOT to Kill your Presentation with your Slides

PowerPoint presentations have become a vital part of both internal and external communications at pharmaceutical and medical device companies. Whether you are from regulatory affairs, charged with presenting information on how to comply with new requirements to the manufacturing team or you are from a small medical device company presenting your product to possible investors, your presentation could mean the lifeblood of your organization. Not only do executives use presentation slides to make pitches to stakeholders, but doctors also use them to present information at meetings and conferences too.

Trial Management Challenges at Academic Medical Centers: Why and How Can Sponsors Help?

Continuously increasing regulatory requirements, operational needs and financial pressures are forcing the Academic Medical Centers (AMCs) to re-evaluate and transform the way clinical research is managed. Many pharmaceutical and medical device companies are cutting back on their R&D budgets and industry has begun to look for new and hopefully less expensive sources of innovation. AMCs seem to be a perfect fit and they are quickly becoming a deal-making hot spot.

Developing a Compliant Data Trending System: FDA Demands & Quality Issues

"You need to develop a strategy for trending and monitoring that is aligned with your goal. We cannot tell you what is appropriate. You need to get the expertise and if you don't have this in-house you need to hire it or contract for it." - Grace McNally of the Office of Compliance in FDA's CDER

Trial Management Challenges at Academic Medical Centers: Why and How Can Sponsors Help?

Continuously increasing regulatory requirements, operational needs and financial pressures are forcing the Academic Medical Centers (AMCs) to re-evaluate and transform the way clinical research is managed. Many pharmaceutical and medical device companies are cutting back on their R&D budgets and industry has begun to look for new and hopefully less expensive sources of innovation. AMCs seem to be a perfect fit and they are quickly becoming a deal-making hot spot.

Developing a Compliant Data Trending System: FDA Demands & Quality Issues

"You need to develop a strategy for trending and monitoring that is aligned with your goal. We cannot tell you what is appropriate. You need to get the expertise and if you don't have this in-house you need to hire it or contract for it." - Grace McNally of the Office of Compliance in FDA's CDER