Biopharmaceutical Regulatory Affairs

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 Affairs

July 29-30, 2019

7th European Biopharma Congress

Stockholm, Sweden
August 02-03, 2019

9th International Conference on Pharmaceutical GMP, GCP & Regulatory Affairs

| Pharmaceutical Research, Education, Expo & Networking | Chicago, USA
August 19-20, 2019

24th World Congress on Pharmacology

Vienna, Austria
September 11-12, 2019

14th World Congress on Pharmacology and Toxicology

Singapore
September 11-12, 2019

World Congress on Drug Discovery and Drug Design

Singapore
September 18-19, 2019

6th World Congress on Natural Products, Medicinal Plants and Traditional Medicines

| Radisson Narita | Tokyo, Japan
September 25-26, 2019 Hong Kong

17th World Congress on Drug Formulation & Drug Delivery

Courtyard by Marriott Hong kong
September 25-26, 2019

Asia Pacific Pharmaceutics & Drug Delivery Congress

Singapore
October 07-08 2019

Global Congress on Pharmacology and Therapeutics

Paris, France
October 07-08, 2019

Innovation in Drug Design Techniques and pharmacology

| Paris, France
October 10-11, 2019

15th World Congress on Medicinal Chemistry & CADD

Dubrovnik | Croatia
October 14-15, 2019

19th World Congress on Advances in Pharmaceutical Sciences

Courtyard Marriott Seoul Times Square | Seoul, South Korea
Oct 23-24 2019

11th Annual Biomarkers and Clinical Research Congress

| Amsterdam, Netherlands
October 25-26, 2019

14th International Conference on Biopharma and Biotherapeutics

| Copenhagen, Denmark
October 23-24, 2019 | Copenhagen, Denmark

12th Pharma Congress

November 04-05, 2019

Advanced Pharmaceutics and Clinical Research

| Paris, France
September 11-12, 2019

2nd Annual Pharmaceutical Biotechnology Congress

Singapore
November 11-12, 2019

20th Annual Pharma Middle East Congress

Istanbul, Turkey
November 14-15, 2019

2nd World Congress on Bioorganic and Medicinal Chemistry

Cape Town, South Africa
November 18-19, 2019

European Congress on Nanomedicine and Pharmaceutical Nanotechnology

Prague, Czech Republic
November 18-19, 2019

European Conference on Pharmacovigilance & Drug Safety

Prague | Czech Republic
November 18-19, 2019

27th Global Experts Meeting on Neuropharmacology

Rome, Italy
November 19-20, 2019

20th Annual Meet on Pharmaceutical Sciences

Bangkok, Thailand
December 02-03, 2019

15th Annual Congress on Pharmacology and Toxicology

Paris, France
April 01-02, 2020

13th European Biosimilars Congress 2020

London, Uk
March 23-24, 2020

23rd Asia Pacific Pharma Congress

Singapore
May 06-07, 2020

15th Annual Meet on Euro Ethnopharmacology

Prague | Czech Republic
May 18-19, 2020

22nd Annual European Pharma Congress

Berlin, Germany

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