Home > Collections > Topics in Regulatory Affairs for Pharmaceuticals
Topics in Regulatory Affairs for Pharmaceuticals
View PDF

Topics in Regulatory Affairs for Pharmaceuticals

Publisher: FX Conferences
  • Description

Stay current on the ever-changing regulatory environment with 10 audio recordings of industry experts offering practical guidance for executives, directors, managers, and associates concerned with regulations in the pharmaceutical market.

Ovid and FX Conferences offer thousands of professional development hours for your teams, conveniently packaged and delivered as a collection of audio recordings to save you time and money.

Topics in this collection have a global appeal and are relevant for multiple departments within your organization—R & D, Market Research, Compliance, and more. Each of the 10 recordings consists of a 45-minute, telephone-based presentation delivered by expert international speakers, followed by a 15-minute question-and-answer session (collection available with and without transcripts).

RECORDINGS:

1. Requests for Off-label Information – The FDA Guidance and Its Implications
Speakers: Wendy Blackburn, Executive Vice President, Intouch Solutions, and Dr. Darshan Kulkarni, Principal Attorney, The Kulkarni Law Firm

2. Preparing for Upcoming Changes in EU Pharmacovigilance Requirements
Speaker: Dr. Jan Petracek, CEO & Chief Consultant, PharmInvent

3. Industry Update – Europe's New Pharmacovigilance Regulations
Speaker: Stefan Blesse, Principal Consultant, Granzer Regulatory Consulting & Services

4. Effectively Managing an FDA Inspection – Opening Meeting to Rapid 483 Response
Speaker: John Avellanet, Managing Director & Principal, Cerulean Associates LLC

5. FDA Update – Responding to Unsolicited Requests for Off-Label Information
Speakers: Marian J. Lee, Partner, and Beverly H. Lorell, Senior Adviser, King & Spalding LLP

6. Centralized vs Onsite Monitoring – Applying FDA's Risk-based Approach
Speaker: Sandra Maddock, President & CEO, IMARC Research, Inc

7. Off-label Promotion – What FDA Looks For & What You Need to Know
Speaker: Alan Minsk, Partner, Arnall Golden Gregory LLP

8. Expedited and Periodic Safety Reporting for Drug Trials
Speakers: Helen Colquhoun, Vice President, Cromsource

9. Following the 510(k) and 505(b)(2) Pathways to Regulatory Approval
Speaker: Dr. Joy Frestedt. President & CEO, Frestedt Incorporate

10. Successfully Responding to FDA 483s and Warning Letters
Speaker: Michael A. Swit, Special Counsel, FDA Practice, Duane Morris LLP

Free Instant Access
This Month

JOTM
Biomedical Research Grants - UberResearch Searchable database of awarded research funding that includes more than 600,000 indexed records. Allows researchers to instantly uncover the funders and dollars going to their discipline and plan their grant outreach accordingly.
JOTM
Evidence-Based Medicine Reviews (EBMR) A definitive resource for electronic information in the evidence based medicine movement that combines the most trusted resources into a single, fully-searchable database.
JOTM
Journal of Urology® Official Journal of the American Urological Association (AUA), the journal brings solid coverage of the clinically relevant content needed to stay at the forefront of the dynamic field of urology.
JOTM
Journal of the Association of Nurses in AIDS Care A forum for nurses and health care professionals who care for and treat individuals infected and affected by HIV/AIDS. Offers the latest in health care delivery, program implementation, research analysis and application.

Noteworthy

Doody's Featured Books
Acute Care Surgery, 2nd Edition
Updated with more illustrations and brand-new chapters that reflect the growth and advances in the field, this edition features an editorial board drawn from the ranks of trauma surgery, emergency surgery, and critical care surgery.

Manual of Cardiovascular Medicine, 5th Edition
Using a practical, outline format, this best-selling title presents evidence-based approaches to cardiovascular diagnosis, diseases, and treatment – perfect for daily practice or exam preparation.