'Reference product' presentation slideshows

ASBM Biosimilars

ASBM Biosimilars. US Prescribers and Biosimilars Naming. Kevin Olson, CEO Industry Standard Research KevinO@ISRreports.com October, 2015. Table of contents. Page 3 Methodology 12 Drug Recording Practices 20 Product Naming Attitudes and Beliefs 32 Substitution Attitudes and Beliefs.

386 views • 38 slides

Regulatory workflow for Registration of Biosimilar products in Egypt

Regulatory workflow for Registration of Biosimilar products in Egypt. Presented by: Dr /Mona Saleh. Biologicals Registration Directorate Central Administration for Pharmaceutical Affairs www.eda.mohealth.gov.eg biosimilars@eda.mohealth.gov.eg. Topics discussed in the presentation.

799 views • 33 slides

Regulatory and Scientific Issues of Biosimilars

Regulatory and Scientific Issues of Biosimilars. Duu-Gong Wu, Ph.D. Executive Director, PharmaNet Member, FDA Alumni Association DIA China, Beijing, China May 16-18, 2011. Disclosures. I am currently an employee of PharmaNet Development Group. I am Executive Director, Consulting Division.

759 views • 31 slides

Regulatory and Scientific Issues of Biosimilars

Regulatory and Scientific Issues of Biosimilars. Duu-Gong Wu, Ph.D. Executive Director, PharmaNet Member, FDA Alumni Association DIA China, Beijing, China May 16-18, 2011. Disclosures. I am currently an employee of PharmaNet Development Group. I am Executive Director, Consulting Division.

315 views • 31 slides

6 th Science & Standards Symposium January 16, 2013 Istanbul Biosimilars

6 th Science & Standards Symposium January 16, 2013 Istanbul Biosimilars. Roger L. Williams, M.D. CEO and Chair, Council of Experts. Topics. BPCI USP Summary. Generic Versus Pioneer Product Equivalence Concepts (CFR 320). Pharmaceutical Equivalence Same active ingredient Same strength

354 views • 27 slides

PREQUALIFICATION OF ANTIMALARIA L DRUG PRODUCTS

Hans Kemmler Consultant to WHO Guilin, 11.Jan. 2006. PREQUALIFICATION OF ANTIMALARIA L DRUG PRODUCTS. Frequently Encountered Deficits in Expression of Interest for Originators. Overview. Prequalification Requirements for Finished Pharmaceutical Products (FPPs) Clinical issues

403 views • 24 slides

Clinical requirement for biosimilar Products

Clinical requirement for biosimilar Products. National Organization for Research & Control of Biological products Dr. Heba Khalil, Head of Marketing Authorization & Clinical Trials Evaluation Departments. What are Biosimilars?.

439 views • 22 slides

Jordi Sabater-Mir, Joan Cuadros and Pere Garcia

398 views • 21 slides

Jordi Sabater-Mir, Joan Cuadros and Pere Garcia

212 views • 21 slides

Transatlantic Administrative Simplification Workshop European Preparatory Roundtable 8.6.2007

Transatlantic Administrative Simplification Workshop European Preparatory Roundtable 8.6.2007. Suzette Kox EGA Senior Director Scientific Affairs. Generic and Biosimilar Medicines - Public Health. Increases access through affordable medicines Stimulates innovation through competition

249 views • 18 slides

Biosimilars : Conversion, Switching, and Educating Prescribers and Patients

182 views • 18 slides

Healthcare Reform--New Path for Biosimilars

Healthcare Reform--New Path for Biosimilars. May 20,2010. Kathleen M. Sanzo, Esq. Ksanzo@morganlewis.com Washington, DC. What the New Law Accomplishes. The Affordable Care Act (ACA) provides for a biosimilar pathway that is not based on an ANDA model.

244 views • 15 slides

Biosimilar & Patents - Challenges for Research & Analysis

164 views • 15 slides

Oncology Biosimilars Market Global Trends, and Forecast till 2026

Biosimilar is a biological product that resembles a reference product and is not difference from the already approved reference product.

40 views • 3 slides