FDAnews Announces — Fixed Dose Combination Drug Development: What’s in Store? Webinar, Feb. 29, 2016

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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.

Fixed Dose Combination Drug Development:
What’s in Store?
Feb. 29, 2016 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/fixeddosecombination

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, on Feb. 29 as he lays out both the specific challenges manufacturers need to confront and the opportunities that are available in the development of fixed dose combination products.

In 90 minutes attendees 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 the 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 attendees will have the inside track on getting their product to market first.

Meet the Presenter:

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.

Who Will Benefit:

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

Webinar Details:
Fixed Dose Combination Drug Development:
What’s in Store?
Feb. 29, 2016 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/fixeddosecombination    

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/fixeddosecombination
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.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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