Live Webinar Review of global strategic drug development opportunities

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 60 Min Live Webinar

"Hear By Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting "

Learn how to plan, control and manage a full global development

Description

Establishing a regulatory strategy for one region requires understanding regulatory requirements and restrictions during development and ultimate commercialization. Managing a regulatory strategy across more tan one region requirescareful thought and preparation to ensure the mst cost-effective, efficient development program. Attend this webinar to learn some of the major considerations and decisions affecting global development and tips for continuous project management

Why You should Attend The Session

Learn how to plan, control and manage a full global development program. Maximize your time and effectiveness.

 

Areas Covered

- - Traditional new drug product development and regional considerations

- - Modified and generic drug product, product development and regional considerations

--  Specialty product regional considerations

• Orphan drugs

• Pediatrics populations

• Antibiotics

• Biologics/ Biosimiliars

- - Additional regulatory opportunities by region

• Small businesses

• Breakthrough therapy

Who will Benefit

• Directors

• Managers

• Supervisors

• Auditors

• Regulatory operations

• Clinical investigators, site management and contracting personnel

• Clinical operations

• Project managers

• Data management

• Medical writers

• Compliance officers

Industries who can attend

This workshop will be beneficial for individuals supporting clinical trials, manufacturing, distribution, marketing, regulatory affairs, compliance, quality control, and quality assurance and anyone required to create SOPs for their job function in a regulated industry


Speaker Profile

Peggy J. Berry.

MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official)

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book "Choosing the Right Regulatory Career" (RAPS, MD) and author of the 2011 book "Communication & Negotiation" (RAPS, MD).

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