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Peggy J Berry

Peggy J. Berry, MBA, RAC, is Keynote Speaker at Compliance key Inc.She 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).

 Webinar Id: LSHCPF001
10:00 AM PT | 1:00 PM ET
 12/12/2017
 Duration 90 mins

Fighting butterflies & presenting with finesse

This webinar will help you bring the visual element to your presentations, along with the ease of presentation. Learn how to captivate your audience, communicate your message, and have fun!


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               $ 179
       Single Attendee
(Only for one Participant)
         $ 363
Multiple Attendee
( 2 - 5 Participants)
          $ 726
Corporate Attendee
( 6 - 10 Participants)
                  $ 237
         Recorded
(6 months unlimited access)
 Webinar Id: LSHCFP001
 View Anytime
 Duration 90min mins

FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials

This webinar will review the current regulations, guidance documents for GMP Documentation in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling,and documentation requirements will also be reviewed and explored.

$ 237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCPBA001
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 Duration 90 mins

Advertising and Promotional material compliance and review process

This webinar will address issues of compliance in the creation of advertising and promotional materials and the appropriate internal assurances that compliance of materials is appropriately assessed, evaluated, and documented. Ensure that your company has a program in place that will ensure full understanding and communication of potential risks associated with materials and ability to mitigate risk through subtle but important modifica........

$ 237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCPJB001
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 Duration 90 mins

Preparing Compliant eCTD Submissions: Are you prepared for upcoming FDA mandate on e-submissions?

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes a........

$ 237  Recorded  (6 months unlimited access)

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 Webinar Id: LSHCPJB002
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 Duration 90 mins

SOP compliance management: A must for the pharmaceutical industry.

This workshop will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within the SOPs.

$ 237  Recorded  (6 months unlimited access)

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