Generic Drugs Forum 2018 – Files Page

Keynote Kathleen Uhl, MD	View Recording
Pharmaceutical Quality Update Michael Kopcha, PhD, RPh	View Recording
ANDA Performance/Operations Update Edward “Ted” Sherwood	View Recording
OPQ Policy Update Brian Hasselbalch	View Recording
Good ANDA Submission and Assessment Practices and Software Support Lisa Bercu, JD Sarah Kurtz, PharmD	View Recording
Challenges in Generic Drug Safety and Surveillance Howard D. Chazin, MD, MBA	View Recording Note: The first 8 minutes of Dr. Chazin’s presentation did not record properly. We will be re-recording his session and will have the new recording posted by May 1
Electronic Submissions Jonathan Resnick	View Recording
Using the ePortal to Submit a pre-ANDA Meeting Kris André	View Recording
Q&A Panel Discussion Sherwood, Hasselbalch, Bercu, Kurtz, Chazin, Resnick, André	View Recording
Pre-ANDA Meeting Process Kris André Katherine Tyner, PhD	View Recording
Orange Book – 101 Kun Shen, PharmD, MS, BCPS	View Recording
Determining Whether to Submit an ANDA or a 505(b)(2) Application Elizabeth Giaquinto Friedman, JD, LLM	View Recording
Q&A Panel Discussion Friedman, Shen, Tyner, Andre, and Kendra Stewart	View Recording

GDUFA II – Review Timelines Vincent Sansone, PharmD, PMP	View Recording
Filing Review Basics – Examples of RTR Bijal Patel, PharmD, BCPS Mavis Mbi, PharmD, RPh.	View Recording
Best Practices for Conducting Bioequivalence Studies Utpal Munshi, PhD	View Recording
Expectations for Including Facility and Site Information in Applications Derek Smith Jia Jian (JJ) Shen	View Recording
Microbiology Quality Assessment Elizabeth Bearr, PhD	View Recording
Integrated Quality Assessment Process Savan Khanna, PharmD	View Recording
Q&A Panel Discussion Khanna, Bearr, Shen, Smith, Munshi, Patel, Mbi, Sansone, and Julia Lee, PharmD and Andrea Bautista, JD, MBA	View Recording
GDUFA II User Fees: Update on Year One Donal Parks MBA, MPM	View Recording
Generic Drug Product Quality Assessment Robert T. Berendt, PhD	View Recording
Drug Substance Quality Assessment: Best Practices Ramnarayan Randad, PhD	View Recording
Application Communications Jennifer H. Nguyen, PharmD Yen Anh Bui, Pharm.D.	View Recording
Laboratory Science to Support Risk-Based Quality Assessments Jason D. Rodriguez, PhD	View Recording
Integrated Process and Facilities Assessment Edwin Jao, Ph.D. B.J. Ryan	View Recording
Q&A Panel Discussion Ryan, Jao, Rodriguez, Anh Bui, Nguyen, Randad, Berendt, and Parks	View Recording