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
Embase® Embase increases the discovery of biomedical evidence to support critical life sciences functions, delivering relevant, up-to-date biomedical information to the global biomedical research community.
JOTM
Food Science & Technology Abstracts FSTA® covers topics relating to every aspect of the food chain including all the major food commodities plus biotechnology, microbiology, food safety, additives, nutrition, packaging and pet foods.
JOTM
American Journal of Gastroenterology As the leading clinical journal covering gastroenterology and hepatology, AJG provides practical and professional support for clinicians dealing with the gastroenterological disorders seen most often in patients.
JOTM
Evidence-Based Practice Evidence-Based Practice is a quarterly journal focused on topics relevant to the daily practice of family medicine and contains content addressing timely and pertinent questions related to patient care.

Noteworthy

Doody's Featured Books
Access Device Standards of Practice for Oncology Nursing
An essential resource for nurses practicing in a wide range of settings to ensure safe, effective care of patients with VADs.

Fundamentals of High-Resolution Lung CT: Common Findings, Common Patterns, Common Diseases, and Differential Diagnosis
Provides a straightforward guide to understanding the high-resolution lung CT (HRCT) assessment of diffuse lung diseases.