01

FDA Regulations

Welcome to JG Business Link International!
It’s my pleasure to have you at our site, and thank you for your interest into our company.

FDA Regulations
FDA-02

US-Korea Drug Development Regulatory
Harmonization Approaches Seminar

  • Period: October 29- November 4, 2014
  • Location: The Turf Valley, Ellicott Coty, MD

    •  

    Innovative Strategies for Pharmaceutical Discovery and Development Seminar with U.S. FDA Officials

  • Period: October 10th, 2012
  • Location: USG Conference Center, MD, USA

    •  

    Session 1. Preclinical Pharmacology and Toxicology for PDD
    Speaker- Yangmee Shin, Ph.D., Senior pharmacologist, Division of Reproductive and Urologic Products, Center for Drug Evaluation and Research, Food and Drug Administration(FDA)

    Session 2. Pharmacokinetics for Clinical Pharmaceutical Development
    Speaker- Hae-Young Ahn, Ph.D., Deputy Director Division of Clinical Pharmacology 3 , Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA

    Session 3. Statistically Valid Design for Clinical Studies
    Speaker – Joo-Yeon Lee, Ph.D., Senior Pharmacometric Reviewer, Division of Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, FDA

    Session 4. Clinical Studies Review for PDD
    Speaker – Jihong Sohn, M.D., Ph.D., Associate professor, Inje University College of Medicine, Sabbatical at Office of Clinical Pharmacology, Center for Drug Evaluation and Research, FDA

    Session 5. Innovative Strategy for Pharmaceutical Discovery and Development (PDD)
    Speaker – Herman Rhee, Ph.D., President of Health Research International

     

    Drug Development Processes & Regulatory Approaches Seminar
    with the Best Instructors in the Field

  • Period: November 7th – 8th, 2013
  • Location: Universities at Shady Grove

    • FDA-03
    Charles Raubicheck – Frommer, Lawrence & Haug, LLP; Elinore M. Mercer, Ph.D., R.A.C. – Cato Research; Brian Malkin – Frommer, Lawrence & Haug, LLP; Jack Snyder, MD, PhD, RAC, DABT, CPI – Cato Research; Judith U. Kim – Sterne, Kessler, Goldstein & Fox, P.L.L.C.; Mohamed Al-Ibrahim, MB ChB, FACP – SNBL Clinical Pharmacology Center; Leo Kim, Ph.D. – Baxter Healthcare

     

    Drug Development Process & Regulatory Approaches: 1 Week Concentrated Education Procedures

  • Period: March 18th – 22nd , 2013
  • Location: University of Maryland School of Pharmacy

    • FDA-04

    Natalie D. Eddington, PhD, Dean of UMD School of Pharmacy; Francis B. Palumbo, PhD, Jd, UMD School of Pharmacy; Hongbing Wang, PhD, UMD School of Pharmacy; Ken Bauer, PhD, PharmD; Thomas C. Dowling, PhD, PharmD; Rajendra Uppoor, PhD, Mpharm; Mohamed S. Al-Ibrahim, MD, SNBL; Joga Gobbura, PhD, UMD School of Pharmacy; Deanna Kelly, PharmD; Michael Terrin, MD, UMD School of Medicine; Raj Madabushi, PhD, US FDA; Sheila Weiss, PhD, UMD School of Pharmacy; James Polli, PhD, UMD School of Pharmacy; Mehul Mehta, PhD, USFDA; Vibhakar Shah, PhD, USFDA; Maureen Kane, PhD, UMD School of Pharmacy