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

Related Conference of Biopharmaceutical Regulatory Affiars

August 28-29, 2018

10th World Congress on Neuropharmacology

Paris, France
September 13-14, 2018

8th World Congress on Chromatography

Prague, Czech Republic | Panorama Hotel Prague | Milevská 7, 140 63 Praha
September 17-18, 2018

15th International Conference on Pharmaceutical Formulations & Drug Delivery

| Philadelphia, Pennsylvania, USA
September 20-22, 2018

17th Annual Congress on Pharmaceutics & Drug Delivery Systems

Prague, Czech Republic | Panorama Hotel Prague | Milevská 7, 140 63 Praha
September 24-25, 2018

Middle East Pharmacy and Pharmaceutical Conference

Abu Dhabi, UAE
September 24-26, 2018

12th World Drug Delivery Summit

(10 Plenary Forums - 1Event)
Chicago, Illinois, USA
September 24-26, 2018

7th International Conference on Clinical Trials

| Chicago, Illinois, USA
(10 Plenary Forums - 1 Event)
September 26-27, 2018

5th International Conference on Clinical Pharmacy and
Health Care

San Antonio, Texas, USA
September 28-29, 2018

11th World Congress on Pharmaceutical Sciences

| Montreal, Canada
October 24-25, 2018

13th International Conference on Biopharma and Biotherapeutics

Boston, Massachusetts, USA
November 05-07, 2018

18th Annual Pharma Middle East Congress

Abu Dhabi, UAE
November 08-09, 2018

17th World Congress on Drug Formulation & Drug Delivery

Auckland, New Zealand
November 14-15, 2018

13th World Congress on Pharmacology and Toxicology

Melbourne, Australia
November 15-16, 2018

9th Global Experts Meeting on Neuropharmacology

Berlin, Germany
November 16-17, 2018

5th Annual Congress on Clinical & Hospital Pharmacy

Tokyo, Japan
February 28-March 01, 2019

Global Pharmaceutical & Pharma Industry Conference

Osaka, Japan
Feb 28-March 01, 2019

Plant Science Conference 2019

Osaka, Japan
Feb 28-March 01, 2019

International Conference on Bio-Pharmaceuticals

Osaka, Japan
April 22-23, 2019

6th World Congress on Drug Discovery & Toxicology

Abu Dhabi, UAE
March 22-23, 2019

5th International Conference on Antibiotics

Chicago, Illinois, USA
March 25-26, 2019

World Congress on Pharmaceutical Biotechnology & Bioengineering

Orlando, Florida, USA
April 15-16, 2019

12th European Biosimilars Congress

Berlin, Germany
April 17-18, 2019

11th World Congress on Pharmacology & Therapeutics

Montreal, Canada
April 17-18, 2019

Annual Neurochemistry and Neuropharmacology Congress

| Montreal, Canada
May 15-17, 2019

4th Annual Congress on Nanomedicine and Drug Delivery

Hyatt Regency Osaka, Japan
May 20-21, 2019

21st Annual European Pharma Congress

Zurich, Switzerland
April 22-24, 2019

20th Asia-Pacific Pharma Congress

Tokyo, Japan
September 11-13, 2019

8th International Conference on Clinical Trials

| Orlando, Florida, USA

Biopharmaceutical Regulatory Affiars Conference Speakers

Recommended Sessions

Related Journals

Are you interested in