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Hecker &
Associates, LLC
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307 North Garfield St.
Arlington, VA 22201-1261
202.297.7708
sandy@hecker-associates.com
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Hecker & Associates supports
professional society, non-profit, and industry
efforts to facilitate global teams, train
regulatory-oriented medical writers, and
improve drug development processes to bring
better drugs and biologics to the market
faster and less expensively. We serve on
multiple management and planning committees
for the Drug Information Association (DIA)
focused on international drug development
topics, global submissions, regulatory
writing, regulatory strategy and submission
issues, and project management. We serve as
mentors to junior professionals, are happy to
field questions about or provide regulatory
writing career advice. We frequently give
talks at/attend professional society meetings
to share best practice updates. These meetings
include:
DIA Annual Meeting, Washington, DC, June 14 –
18, 2020; Speaker, “Needs, Challenges, and
Strategies: Efficiently Harmonizing Other
Region Safety Regulatory Reports with FDA” in
the Session “Development, Alignment, and
Maintenance of Safety-informing Regulatory
Documentation.”
DIA Pharmacovigilance and Risk Management
Strategies Conference, Washington, DC, January
27 – 29, 2020
DIA Pharmacovigilance and Risk Management
Strategies Conference, Washington, DC, January
23 – 25, 2017
DIA Annual Meeting, San Diego, CA, June 15 –
19, 2014; Judge, for Amgen’s 2nd annual
“Regulatory Writing Jeopardy” session
DIA Clinical Forum, Dublin, Ireland, October 7
– 9, 2013; Program Committee member and
Co-chair, Medical Writing track
DIA Annual Meeting, Boston, MA, June 23 – 27,
2013: Judge, for Amgen’s “Regulatory Writing
Jeopardy” session, and Speaker: “PSUR/PBRER
Submission Strategies and Special Requirements
in the EU and the US,” in the session
“Periodic Reporting in Drug Safety: From
Safety Updates to Continuous Safety Monitoring
and Benefit-risk Evaluations.”
DIA Annual Meeting, Philadelphia, PA, June 24
– 28, 2012; Session Organizer: “Efficient
Regulatory Medical Writing for Global
Submissions Including “ICH Outlier”
Authorities,” and Speaker: “A Writer’s
Perspective on Safety Documents Before the
Marketing Application,” in the session
“Wrangling the Bestiary of Safety Documents:
Coordination and Integration Across Multiple
Requirements.”
DIA Clinical Forum 2011, Basel, Switzerland;
Cross Functional Working for Better Results,
October 10 – 12, 2011; Speaker: “US
Agent-Appropriate Writing” in the session
“European Sponsor Success with FDA.”
DIA Annual Meeting, Chicago, IL, June 19 – 23,
2011; Session chair “Constructing Key Clinical
Documents for Global Use.”
DIA Annual Meeting, Washington, DC, June 13 –
17, 2010; Session chair and Speaker: “Medical
Writing for Global yet Harmonized CTA
Submissions,” in the session “INDs with a
Global Focus,” and “Safety Report
Considerations in Clinical Trials: What to Do
and What not to Do,” in the session:
“Reporting Safety Data in FDA Marketing
Applications: Is There a Change in FDA
Expectations?”
RAPS eCTD Advanced Workshop, Rockville, MD,
April 19 – 21, 2010; Speaker: “Safety
(Nonclinical) Content Overview.”
exl pharma, 2nd Leveraging Global eCTD
Efficiencies; eCTD Submission Management &
Standards for a Global Regulatory Landscape,
Washington, DC, January 11 – 12, 2010;
Speaker: “Document Granularity for Existing
Products.”
DIA Clinical Forum, Nice, France, October 19 –
21, 2009; Speaker: “Writing the Development
Safety Update Report (E2F): What You Need to
Know” in the session: “Best Medical Writing
Practices in the Outsourcing of Aggregate
Safety Reports.”
DIA Annual Meeting, San Diego, CA, June 21 –
25, 2009; Session chair and Speaker: “Deciding
Placement for IND Foreign Clinical Data to
Facilitate Strategic Lifecycle Maintenance” in
the session: “IND to CTD in Electronic Format:
Strategic Considerations for Lifecycle
Maintenance.”
DIA Annual Conference for Electronic Document
Management, Philadelphia, PA, February 11-13,
2009; (speaker): “Deciding Strategic Placement
for IND Foreign Clinical Data to Facilitate
Lifecycle Maintenance.”
DIA Annual Meeting, Boston, MA, June 22-26,
2008; Speaker in the session: “Best Practices
for Acting as a US Agent.”
DIA Clinical Forum 2007; Global Trends in
Medical Writing and the Evolving Regulatory
Environment, Madrid, Spain, October 17-19,
2008; Program Committee and Session Chair
“Electronic Clinical Trial Application Best
Practices.”
DIA Annual Meeting, Atlanta, GA, June 17-21,
2007; Speaker and Session chair: “Tailoring
the IB to IMP Development Status and Region”
in the session: “The Evolving Role of the
Investigator Brochure in Global Submissions”
and Speaker: “Submitting an IND in eCTD Format
to CDER: Determining Appropriate Placement of
Clinical Information” in the session:
“Submitting an IND in eCTD Format: Lessons
Learned.”
DIA Annual Conference for Electronic Document
Management, Philadelphia, PA, February 6-9,
2007; Speaker and Tutorial Chair: “Placing the
Clinical IND Sections in the eCTD Format” in
the tutorial: “Writing the CTD – Learning from
Best Practices” and Panelist in the
Post-conference Workshop: “Are We Providing
Useful Summary Documents?”
DIA Annual Meeting, Philadelphia, PA, June
18-22, 2006; Session chair and Speaker:
“Achieving an Effective Process Quickly,
Without Sacrificing Quality” in the session:
“Review and Outsourcing Strategies.”
DIA Annual Conference for Electronic Document
Management, Philadelphia, PA, February 7-10,
2006; Speaker: “Adapting the IB for the
Development Life Cycle” in the session:
“Burning Issues in Medical Writing: Ask the
Experts Panel.”
DIA Annual Workshop on Medical Writing,
Washington, DC, October 24-25, 2005; Session
chair and Speaker: “Protocol Considerations to
Meet CTA Requirements in Canada, the EU,
Japan, and the US Simultaneously” in the
session: Global Clinical Trial Applications
and (speaker) “Writing Clinical Submission
Documents for Europe (Particularly if You’re
Not European)” in the session: The CTD:
Writing for the Medical Reviewer.
DIA Annual Meeting, Washington, DC, June 26 –
30, 2005; Speaker: “The Art of Writing Safety
Narratives” in the session: “Discovering and
Reporting Safety Issues in Clinical Trial
Data.”
RAPS 2004 Annual Conference & Exhibition,
Washington, DC, October 10-13, 2004; Speaker:
“Overview of EU Medical Product Legislation,
Medicinals: Background and Organisation,”
“Medicinal Products, Clinical Trials,” and
“Medicinal Products: Post Marketing
Requirements” at the preconference meeting “An
Overview of EU Regulatory Requirements for
Medicinal Products and Devices.”
RAPS Principles and Practices of EU Regulatory
Affairs, Arlington, VA, September 13-14, 2004;
Speaker: “Overview of EU Drug/Biologic
Legislation” and “Post-Marketing
Responsibilities of the Marketing
Authorisation Holder.”
DIA Annual Meeting, Washington, DC, June
13-17, 2004: Speaker: “If the New Format Fits,
Share It: Options for Fitting the ISS and ISE
Analyses into the CTD Format.”
DIA EuroMeeting, Prague, Czech Republic, March
10-12, 2004: Speaker: “Is the CTD Format
Usable for Clinical Trial Applications?” in
the Session: European Directive on Clinical
Trials, Current Implementation Status in the
15 Member States and in the Industry.
RAPS Principles and Practices of EU Regulatory
Affairs, Arlington, VA, February 23-24, 2004;
Speaker: “Overview of EU Drug/Biologic
Legislation,” “Marketing Applications/CTD,”
and “Overview of Clinical Trials.”
DIA European Workshop on Medical Writing,
Paris, France, February 12-13, 2004; Speaker
“Fitting a Clinical Trial Application into the
CTD format, Cinderella’s Glass Slipper.”
DIA Practical Implementation of the Common
Technical Document (CTD), Arlington, VA,
December 8-9, 2003; Speaker: “If the New
(Format) Fits, Share It: Options for Fitting
the ISS and ISE Analyses into the CTD Format.”
RAPS 2003 Annual Conference & Exhibition,
Baltimore, MD, October 19-22, 2003; Session
Chair and Speaker: “The Common Technical
Document: Where Have We Been and Where Are We
Going?”
DIA 39th Annual Meeting, San Antonio, TX, June
15-19, 2003; Speaker: “Regulatory
Submissions–Requirements for Successful
Medical Writing.”
DIA 4th Annual Workshop in Japan for Medical
Writing, Tokyo, Japan, May 15-16, 2003;
Speaker: “Submission Strategies: US and
Europe.”
Barnett International, Implementing the Common
Technical Document. Hands-on Strategies for
Practical Implementation and Compliance,
Philadelphia, PA, April 2-4, 2003; Speaker:
“CTD Basics: Regional Considerations for
Global Success.”
RAPS Education Program, Alexandria, VA, March
17-18, 2003; Program Chair, Session Chair, and
Speaker: “Submission Strategies and Review
Processes.”
DIA Medical and Technical Writing Workshop,
Baltimore, MD, October 21-22, 2002; Program
Committee, Session Chair and Speaker:
“Presentation of Documents: Industry and FDA
Perspective.”
RAPS 2002 Annual Conference, Washington, DC,
October 6-9, 2002; Session Chair and Speaker:
“So You Want to be a Consultant…?” and Session
Chair and Speaker: “EU Legislative Update” (a
review of the current status of important
initiatives such as EU Directive 2001/20/EC,
the clinical trials directive).
DIA Annual Meeting, Chicago, IL, June 16-20,
2002; Session Chair and Speaker: “Style, You
Either Have it or You Don’t: Style Guides and
Standard Formats.”
RAPS 2002 European Annual Conference,
Budapest, Hungary, May 7-9, 2002; Program
Committee and Speaker: “Writing and Review
Processes to Ensure Regulatory Submission
Quality” and “PSURs: Global Considerations for
New and Old Products.”
RAPS RA/QA 101 An Introductory Regulatory and
Compliance Workshop, Arlington, VA, April
25-26, 2002; Program Committee and Speaker
“The Product Development Pipeline,” “Marketing
and Post-Approval Regulatory Processes,”
“Global Perspectives,” and “Career Ladders.”
DIA Workshop: Practical Implementation of the
Common Technical Document (CTD), Arlington,
VA, April 22-23, 2002; Speaker: “Facilitating
Global Team Creation of the Clinical Sections
of a CTD.”
Gardner Carton & Douglas, Biotech and
Healthcare Industries Strategies for Success
2001-2002 Seminar Series, Clinical
Trials–Biotech and Healthcare Compliance
Issues, Washington, DC, February 27, 2002;
Speaker: “Compliance Issues to Consider When
Establishing a Clinical Trial.”
RAPS Global Awareness: European Drugs and
Biologics, Alexandria, VA, January 15-16,
2002; Program Committee and Speaker
“Considerations and Regulations for Clinical
Trials of Drugs and Biologics.”
RAPS ICH Progress, Alexandria, VA, January 14,
2002; Program Committee Chair and Speaker “The
Clinical Trial Report Guideline (E3) Six Years
On: Progress and Its Role in the US, EU and
CTD.”
RAPS 2001 Annual Meeting, Baltimore, MD,
November 4-7, 2001; ICH Session Chair and
Speaker “The Clinical Trial Report Guideline
(E3) Six Years On: Progress and Its Role in
the US, EU, and CTD.”
DIA Medical and Technical Writing Meeting,
Vienna, Austria, October 11-12, 2001;
“Creating an Author – Medical Writer Team:
Practical Tips” and “Team Creation of Timely
High Quality Clinical Trial and Marketing
Applications.”
DIA Annual Meeting, Denver, CO, July 8-12,
2001; “Insights into Producing Timely, High
Quality Marketing Applications–a Sponsor-CRO
Dialog.”
DIA Medical and Technical Writing Meeting,
Baltimore, MD, October 5-6, 2000; “Successful
Clinical Trial and Marketing Applications
Writing.”
DIA Annual Meeting, San Diego, CA, June 11-15,
2000; CRO/Sponsor Writing Partnership: “Keys
to Successful Team Writing of Applications.”
DIA, Survival Skills for Medical Writers,
Dublin, Ireland, October 7-8, 1999;
CRO/Sponsor Writing Partnership: “You Want It
When?”
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