< Back
EMWA Logo EMWA Logo
 

Sam Hamilton

Company:
Sam Hamilton Medical Writing Services Ltd
Qualification:
PhD
Leader background:
Sam Hamilton is a postdoctoral virologist, currently employed as Global Head of Medical and Regulatory Writing and Public Disclosure for the CRO, Clinipace Worldwide. Sam has over 25 years in clinical and regulatory medical writing roles in the pharmaceutical industry, both employed and as a freelancer, and is independently responsible for her wider professional interests. Sam has a special interest in the area of public disclosure of clinical-regulatory documents as Chair of the EMWA-AMWA group who delivered the open-access www.core-reference.org in May 2016. CORE Reference is the only known open-access resource that pinpoints the sections in an ICH E3-compliant CSR that are potentially affected by public disclosure. Sam is long-time supporter of EMWA serving in various roles over 12 years, notably as Freelance Advocate; Editorial Board member for Medical Writing (MEW; journal); Workshop Leader; Expert Seminar Series (ESS) Chair; and Vice President and President of the Executive Committee (EC). Sam was elected an EMWA Lifetime Fellow in 2018 for her services to the association, and is currently MEW Section Editor for the “Regulatory Public Disclosure” Section and on the Advisory Panel of the Regulatory Public Disclosure Special Interest Group
Workshops:
Scheduling and Proposal Writing: The Clinical Study Protocol and Report
    Level: Advanced Area: Professional Techniques
    Code: PTA6 Duration: 03:30:00
Good SOP Practice: Processes and Authoring
    Level: Foundation Area: Drug Development
    Code: DDF18 Duration: 03:30:00
Clinical Study Report Appendices
    Level: Foundation Area: Drug Development
    Code: DDF5 Duration: 03:30:00
Freelance Business Forum
    Level: Area: Discussion Forum
    Code: F1a Duration: 01:45:00
EMWA Budapest Working Group: Clarity and Openness in Reporting: E3-based
    Level: Area: Not for credit
    Code: XPBGW Duration: 00:40:00
CORE Reference - Clarity and Openness in Reporting: E3-based
    Level: Foundation Area: Drug Development
    Code: DDF38 Duration: 03:30:00
CORE Reference - Clarity and Openness in Reporting: E3-based
    Level: Foundation Area: Drug Development
    Code: DDF38a Duration: 03:30:00
Update on CORE
    Level: Area:
    Code: Sym5.8 Duration: 00:15:00
CORE Reference - Clarity and Openness in Reporting: E3 based
    Level: Foundation Area: Drug Development
    Code: DDF38b Duration: 03:30:00
CORE Reference - Clarity and Openness in Reporting: E3 based
    Level: Foundation Area: Drug Development
    Code: DDF38c Duration: 03:30:00
An update on CORE reference - news, initiatives, and developments
    Level: Area: Expert Seminar Series
    Code: ESS32.5 Duration: 00:25:00