Biopharmaceutical Regulatory Affiars

Regulatory Science is the science of advanced standards equipment, and paths to assess the safety, Drug toxicity and quality, potency of all FDA-regulated products. An access to lengthen the programs in regulatory science that leverages what has been well-educated in the development of training programs for translational scientists, and this model for regulatory science program development is being refined and adopted by all of the institutions that are part of the CTSA network. The target audience for such a program is broad, noted that it is necessary to break out of the mindset that regulatory science resides totally with FDA and that the field's purpose is to create a workforce that will function within the FDA. Regulatory science is a collaborative effort that goes beyond FDA. Critical needs for a regulatory science training program understand research and scientific methodology, toxicology, therapeutics, and pharmacology that underpin the regulatory process.

  • Biopharma Regulatory challenges
  • Regulatory Approvals for Biopharma drug products
  • Overview of drug, biologic and device regulatory pathways
  • Role of Regulatory Authorities
  • BPCI Act
  • Hatch-Waxman Act

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10th World Congress on Pharmacology

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14th World Congress on Pharmacology and Drug Safety

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8th World Congress on Chromatography

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15th International Conference on Pharmaceutical Formulations & Drug Delivery

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17th Annual Congress on Pharmaceutics & Drug Delivery Systems

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(10 Plenary Forums - 1Event)
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(10 Plenary Forums - 1 Event)
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Boston, Massachusetts, USA
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18th Annual Pharma Middle East Congress

Abu Dhabi, UAE
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17th World Congress on Drug Formulation & Drug Delivery

Auckland, New Zealand
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13th World Congress on Pharmacology and Toxicology

Melbourne, Australia
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9th Global Experts Meeting on Neuropharmacology

Berlin, Germany
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5th Annual Congress on Clinical & Hospital Pharmacy

Tokyo, Japan
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6th World Congress on Drug Discovery & Toxicology

Abu Dhabi, UAE
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5th International Conference on Antibiotics

Chicago, Illinois, USA
March 25-26, 2019

World Congress on Pharmaceutical Biotechnology & Bioengineering

Orlando, Florida, USA
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12th European Biosimilars Congress

Berlin, Germany
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11th World Congress on Pharmacology & Therapeutics

Montreal, Canada
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Annual Neurochemistry and Neuropharmacology Congress

| Montreal, Canada
May 20-21, 2019

21st Annual European Pharma Congress

Zurich, Switzerland
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8th International Conference on Clinical Trials

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Biopharmaceutical Regulatory Affiars Conference Speakers

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