FDAnews Announces Emerging Biopharmaceutical Therapies: New Regulations, New Guidelines, New Incentives, New Challenges, Sept. 27, 2017, Washington, DC

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Jul 17, 2018, 00:00 ET

FALLS CHURCH, Va. (PRWEB) July 17, 2018 -- Gene therapy. Modified human cells. Personalized medicine. Combination products. The brave new world of bio-innovation is delivering bonanza profits for many a drug and biotech manufacturer.

But along with the profits come problems, FDA problems. Including wow to regulate what could be viewed as a new industry. The agency is feeling its way — and that affects pharmaceutical and biotech companies.

It’s time to find out what it’s OK (and not OK!) to do today, tomorrow and in the weeks and months to follow.

FDAnews has called on a top drug regulation expert, Christine (Chris) Markus Esq. of King & Spalding LLP, to guide manufacturers through the legal and regulatory maze. It’s an all-day session featuring lectures, cases, chalk-talks and plenty of back-and-forth. Attendees will return home fully briefed on how to comport themselves in the current regulatory climate and prepare for what lies down the road.

Here’s just a sampling of what attendees will cover:

  • Red flags: Product characteristics that raise regulatory classification and evaluation challenges
  • Novel products: Why they may not fit into current regulatory regimes
  • How precedent applies: Recent laws, FDA guidances and review precedents
  • FDA interpretations: How the agency is adapting existing precedents to novel products
  • Informed consent: How it may change to enable research use of biospecimens, including recent amendments and practical risks associated with consent
  • Product approvals: How recent regulatory actions may affect them
  • Tricks of competitors: Approval strategies that are working for others
  • Capitalizing on incentives: Incentives exist for product development and may facilitate regulatory interactions
  • Practical take-home strategies: Tips for getting what’s needed from the FDA
  • And much more

The conference takes place in the heart of the Nation’s Capital, surrounded by fine dining, shopping and world-class museums. Consider adding on a day or a long weekend to enjoy what Washington has to offer.

Drug development science, technology and manufacturing techniques are moving at a breakneck pace. The FDA is playing catch-up, but playing hard. Learn the rules as they stand, as they’re evolving, where they may wind up.

Meet the Chairperson:
Christina (Chris) Markus Esq., a partner and Deputy Chair of the FDA & Life Sciences practice at King & Spalding LLP, has more than 25 years’ experience counseling pharmaceutical and biotech manufacturers, researchers, and related companies on regulatory strategy, product development, commercialization, and compliance matters. She is an expert on the evolution of product regulation including how Congress, the FDA, and other agencies have adapted decades-old laws to address rapid and continuing technological development. She is a frequent speaker and author on regulatory law matters.

Who Will Benefit:
Drug, biologics, combination products makers, investors and lenders will find value in this workshop, especially individuals with the following responsibilities:

  • Regulatory specialists
  • QA/QC team
  • Legal counsel
  • Managers/Directors
  • Business development
  • Strategic planners

Conference Details:
Emerging Biopharmaceutical Therapies:
New Regulations, New Guidelines, New Incentives … New Challenges
**Presented by FDAnews**
Sept. 27, 2018 – Law Offices of King & Spalding LLP • Washington, DC
http://www.fdanews.com/biopharmatherapies

Tuition:
Early Bird Pricing: $697 (available until Aug. 24, 2018)
Regular Pricing: $897 (after Aug. 24, 2018)
Livestreaming Options are available
Significant team discounts are available.

Easy Ways to Register:
Online: http://www.fdanews.com/biopharmatherapies
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

Michelle Butler, FDAnews, http://www.fdanews.com, +1 703-538-7660, [email protected]