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Cell & Gene Therapy Strategies for Successful BLA Submissions - Webinar Recording/ Transcript

$287.00
Scott R. Burger, MD — Principal, Advanced Cell and Gene Therapy —discusses the FDA’s requirements for successful BLAs and how to comply and make you aware of the common mistakes and how to avoid them. View

Outsourcing Facility Compounding - Webinar Recording/Transcript

$287.00
Lee H. Rosebush — partner at Baker Hostetler and chairman of the Outsourcing Facilities Association — will address the newly proposed outsourcing facility compounding standards and will discuss several outstanding questions the industry must confront. View

Biosimilars Regulation - Webinar Recording/Transcript

$287.00
Nicholas Mitrokostas, partner in the Boston office of Goodwin Procter LLP and Daniel Orr, partner in the Washington, DC office of Womble Bond Dickinson LLP, will provide an overview of the FDA’s current review process, approval standards, and related issues confronting sponsors of reference biologics and biosimilars. View

Building a World-Class Drug Supply Chain - Webinar Recording/Transcript

$287.00
Many manufacturers have acquired the skills and capabilities necessary to “serialize” products, but they are far from efficiently running their manufacturing and supply chain operations. View

Regulating Software Used by Life Science Manufacturers - Webinar Recording/Transcript

$287.00
Life science companies using software in clinical trials, software developers, and producer of artificial intelligence products need to know what software is a medical device and what’s not. View

Laboratory Developed Tests, In Vitro Diagnostics & Gene Therapies - Webinar Recording/ Transcript

$287.00
In 90 fast-paced minutes attorneys Mike Druckman and Blake Wilson of Hogan Lovells US LLP will provide insights into how under DAIA the framework for LDTs, companion devices and targeted pharmaceutical therapies may change in the near future, and how to start preparing for these changes. View

Chinese Medicine: The Dangers of Deployment - Webinar Recording/Transcript

$287.00
Rosmary Gibson — Senior Advisor at the Hastings Center and author of China Rx: Exposing the Risks of America’s Dependence on China for Medicine discusses the real-world impact of Chinese medicine on public health and the scrutiny it’s undergoing. View

REMS: Requirements, Regulation, and Enforcement - Webinar Recording/Transcript

$287.00
REMS has evolved into a powerful enforcement tool. FDAnews has called on Anne K. Walsh, a Washington, D.C. attorney to discuss why the REMS evolution has occurred and how to prepare for future changes. View

Brexit and the Impact to Your Global Business Operations - Webinar Recording/Transcript

$287.00
Your international drug and device business is at a crossroads known as Brexit — the withdrawal of the United Kingdom (UK) from the European Union (EU). What can you expect? View

FDA’s New Biosimilars Plan - Webinar Recording/Transcript

$287.00
To date 12 biosimilar products have been approved by the FDA — but only 3 have reached the market. FDAnews has enlisted the help of consultant Nitisha Pyndiah to spell out what you need to know about the FDA’s Biosimilars Action Plan — what the FDA is thinking, where the industry is heading, and how you can gain competitive advantage. View

The CDER Reorganization: What It Means for Drugmakers - Webinar Recording/Transcript

$287.00
Drug, biologics and combination product makers with new drug approvals (NDA) in the pipeline are bracing for fallout from the planned reorganization of CDER, the Center for Drug Evaluation and Research. View

Complying with Advertising & Promotion Requirements - Webinar Recording/Transcript

$287.00
From Washington (the FDA, the FTC) to the states (attorneys general) to City Hall, dozens of agencies take an interest in the way you advertise and market your products. Take a crash course in dealing with this panoply of enforcers. View