Fixed Dose Combination Drug Development - Webinar CD/Transcript

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Fixed Dose Combination Drug Development: What’s in Store?

Fixed dose combination products are a front burner issue in the life cycle of pharmaceutical products, garnering increased attention from all stakeholders in the development of new chemical entities.

However, the complexity of formulating and testing multiple APIs, coupled with the business pressure to deliver new products on time and on budget, are substantial stress factors for corporate R&D departments.  And, of course, the evolving — and equally complex — regulatory changes present yet another daunting challenge. The need to stay on top of this seemingly perpetually changing issue is paramount.

Join industry expert Ravi Harapanhalli, Principal of FDAPharma Consulting,  as he lays  out both the specific challenges you need to confront and the opportunities that are available in the development of fixed dose combination products.

In 90 minutes you will learn the:

  1. Present and likely future of fixed dose combination products, the benefits and risks of rapid development, and the value of these products to patients and your company.
  2. Pre-formulation, formulation, and analytical challenges and strategies associated with fixed dose combination products.
  3. Technical challenges associated with developing fixed dose combination products for various routes of administration.
  4. Current and likely future of the regulatory scheme for developing fixed dose combination products.

At the end of this you’ll have the inside track on getting your product to market first.

  • Compliance personnel
  • Regulatory affairs professionals
  • QA/QC personnel
  • Manufacturing executives
  • 510K application specialists
  • Strategic planner
  • Pharmaceutical scientists

Ravi S. Harapanhalli is Principal of FDAPharma Consulting. He formerly was a Vice President at PAREXEL Consulting for 3 years where he served clients in the area of CMC/Biopharmaceutics and general regulatory areas covering drugs, biologics, biosimilars, and combination products. He also worked at FDA for a dozen years, reviewing several drug/biologic/combination product applications and participating in inspections covering various dosage forms and complex drug substances. He was a Branch Chief in the Office of New Drug Quality Assessment for 4 years before joining PAREXEL. He was an instructor and researcher at Harvard Medical School and the University of Medicine and Dentistry of New Jersey (Rutgars). He also worked at Hoechst Pharmaceuticals in the area of antibiotics. He has doctorate in Organic Chemistry (IIT, Bombay), and is a diplomat of the American Board of Science in Nuclear Medicine. He has published more than 30 peer reviewed articles and frequently speaks at national and international conferences on various emerging topics in the drug development and approval process.