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| Issue Date |
Content
|
|
December -2009 |
- Regulatory Outlook and Forecast for 2010
- General FDA forecasts
- Enforcement expectations
- Guidance documents expected
- Longer-term (2011 and beyond) outlook
- Book of Month: The Predictioneer's Game
- Bonus Online Content:
-
Annual trend watch and recommendations roundup (p. 9-19)
-
Transatlantic Administration Regulatory Harmonization Action Plan
-
Get to Market Now! excerpt
|
|
November -2009 |
- Compliance Intelligence, Know-How & Staffing
- Five Compliance Program Mistakes to Avoid
- Trend Watch
- Enforcement Analysis: Adverse Event Reporting
Warning Letter Citations
- Expert: Part 11 and Anti-Virus Software
- Leadership: Year-End Budgeting Tips
- Book of Month: Fundamentals of US Regulatory
Affairs
- Bonus Online Content:
-
Compliance Intelligence, Know-How & Staffing (cont'd, p. 9-11)
-
EMEA concept paper on revisions to Chapter 7 covering CMO
qualification
-
GAO report on FDA device inspection trends
-
HHS report on FDA's handling of adverse event reports
-
Health Canada's draft guidance on GLP data
-
FDA guidance on clinical investigator responsibilities and
delegation
-
Personal year-end closeout checklist
|
|
October-2009 |
- Two FDA Officials on Supplier Qualification and
Management Expectations
- Self-Centered Compliance
- Trend Watch
- Enforcement Analysis: FDA Sterilization
- Expert: Part 11 Status
- Leadership: Driving Decisions in Meetings
- Book of Month: Fierce Leadership
- Bonus Online Content:
-
Two FDA Officials on Supplier Controls (cont'd, p. 9-11)
|
|
September-2009 |
- Former FDA Prosecutor on Document Mistakes
- Controlling Data Integrity for the FDA
- Trend Watch
- Enforcement Analysis: FDA sampling expectations
- Expert: Generation considerations for inspections
- Leadership: 30 minutes to better priorities
- Book of Month: The Future Arrived Yesterday
- Bonus Online Content:
-
Former FDA Prosecutor interview (cont'd, p. 9-12)
-
Competitive Institute Comments on Draft Guidance on Risk
Information
|
|
August-2009 |
- 17 Lessons from the KV Pharmaceuticals Consent Decree
- Steps to Qualify Virtual Suppliers of Raw Materials
- Trend Watch
- Enforcement Analysis: FDA CAPA expectations
- Expert: Dealing with increased FDA stringency for
enforcement
- Leadership: Tips on turning meetings into action items
- Book of Month: Lean for Dummies
- Bonus Online Content:
-
17 Lessons from the KV Pharma Consent Decree (cont'd, p. 9-14)
-
KV Pharmaceuticals Consent Decree
-
KV Pharmaceuticals FDA Form 483
-
EMEA Human Biosimilar Guideline
-
ICH E16 Genomic Biomarker Submissions
|
| July-2009 |
- Qualifying Virtual Consultants and Teleconsultants
- Quality by Design and Regulatory Submissions
- Trend Watch
- Enforcement Analysis: Training effectiveness and
warning letters
- Expert: Accounting for clinical trial underreporting in
regulatory submissions
- Leadership: Tips on improving your presentations and
training
- Book of Month: On Managing Through a Downturn
- Bonus Online Content:
-
Qualifying Virtual Consultants (cont'd, p. 9-14)
-
Health Canada's new GMPs for 2009
|
June-2009
(free issue #1) |
- Developing an FDA Records Discovery Strategy
- An Analysis of FDA's 5-Year PDUFA Plan: Where are
We?
- Trend Watch
- Enforcement Analysis: Contract supplier audits
- Expert: Retaining biosamples
- Leadership: Boosting employee compliance buy-in
- Book of Month: The Future of Medicine
- Bonus Online Content:
-
FDA PDUFA 5-Year Plan
-
EMEA Guidance: ICH Q8, Q9, Q10 Questions & Answers
-
EMEA Guidance: GCP Inspection Coordination
-
FDA Discovery Strategy (cont'd, p. 9-16)
-
Sedona Principles on E-Discovery
-
Sedona Commentary on Records Litigation Holds
-
Excerpts of the FRCP Amendments and Advisory Committee
Comments
|
May-2009
(free issue #1) |
- Managing Records in the Lab
- FDA Compliance: Where Do We Go from Here?
- Trend Watch
- Enforcement Analysis: Data required to support efficacy
and superiority claims
- Expert: Fun with process mapping
- Leadership: Minimizing outsourcing risk
- Book of Month: The Fiefdom Syndrome
- Bonus Online Content:
-
FDA Guidance: OTC Drug Labeling (Small
Business Series)
-
FDA Guidance: Label Readability (draft)
-
GHTF Guidance: Post-Market Clinical Follow-Up
Studies
-
Untitled Letter: Sanofi-Aventis Taxotere
|
| Apr-2009 |
- Ten Signs Potential FDA Trouble for You is Ahead
- Personalized Medicine and Compliance Costs - Part Four:
Knowledge, Information and Innovation
- Trend Watch
- Enforcement Analysis: Clinical Sponsor Warning Letter
Break-down
- Expert: Post-Approval CMC Guidance from FDA
- Leadership: Encouraging Accountability
- Book of Month: Management Challenges for the
21st Century
- Bonus Online Content:
-
Part Four (cont'd): Personalized Medicine and
Compliance Costs (p. 9-19)
-
FDA Guidance: Exploratory IND Studies (Phase
0 Clinical Studies)
-
Health Canada Guidance: CMC Quality in
Clinical Trial Applications
|
Mar-2009
|
- Six Costly IT Compliance Mistakes
- Personalized Medicine and Compliance Costs - Part Three:
University Collaborations in Developing Personalized
Medicines
- Trend Watch
- Enforcement Analysis: Q1 2009 Warning Letters
- Expert: GLP Enforcement by FDA
- Leadership: Progressive Discipline Policies
- Book of Month: Revolutionary Wealth
- Bonus Online Content:
-
Part Three: Universities and Personalized Medicine (p. 9-17)
-
GHTF Guidance:
Supplier Product and Services Controls
-
GHTF Guidance:
Registration of Manufacturers
|
|
Feb-2009 |
- Insider Information Theft
- Personalized Medicine and Compliance Costs - Part Two
- Trend Watch
- Expert: Scheduling Product Development "Go/No-Go"
Decisions
- Leadership: Improving Presentation Impact
- Book of Month: Out of Our Minds - Learning to
be Creative
- Bonus Online Content:
-
Part Two: Personalized Medicine Compliance Cost Strategies
(pages 7-13)
-
FDA Guidance:
Good Importer Practices
|
|
Jan-2009 |
- Integrating IT, Quality and Regulatory Affairs
- Personalized Medicine and the Cost to Compliance - Part
One
- Trend Watch
- Expert: Top Compliance Worries of 2009
- Leadership: Budget Reviews
- Book of Month: The Regulatory Challenge of
Biotechnology
- Bonus Online Content:
-
Part One: Personalized Medicine and the Cost to Compliance
(pages 7-17)
-
Virtualization and Validation: An Analysis
|
| Issue Date |
Content
|
Dec-2008
|
- Tackling Today's Challenges - Five Tips
- 2009: A Look Ahead at the FDA
- Trend Watch
- Expert: More tips to save money on audits
- Leadership: Closing out the year
- Book of Month: The FDA and Worldwide Quality
System Requirements Guidebook for Medical Devices
- Bonus Online Content:
-
More 2009: A Look Ahead (with 34 more
recommendations)
-
Year-end closeout checklist for busy executives
-
Quick summary of 2008 books of the month
|
| Nov-2008 |
- Ensuring Effective eCTD Submissions
- Tripling your Audit Return on Investment
- Trend Watch
- Expert: Assessing if your SOPs slow your business
- Leadership: Employee Efficacy
- Book of Month: 7 Steps to Better Written
Policies and Procedures
|
| Oct-2008 |
- Controlling Costs without Letting Results Slide
- More Pharma Executives Lessons from the Courtroom
- Trend Watch
- Expert: Quality by Design and Process Validation
- Leadership: The Cost of Employee Loss
- Book of Month: The Halo Effect
|
| Sep-2008 |
- Intellectual Property Theft on the Rise
- Confusion Over GMP Phase I Clinical
Requirements
- Trend Watch
- Expert: FDA Requires ICH Compliance
- Leadership: Busting Silos
- Book of Month: Slack
|
| Aug-2008 |
- FDA Reform: What to Expect
- Lessons You May Not be Learning from the Merck Vioxx Trials
- Trend Watch
- Expert: FDA Guidance on Phase I
- Leadership: Avoiding Analysis Paralysis
- Book of Month: Statistics for Six Sigma Made Easy
|
| Jul-2008 |
- Challenges of Quality by Design
- PAT and Working with IT
- Trend Watch
- Expert: Quality by Design and Biologics
- Leadership: Seeking the Big Picture
- Book of Month: Getting Things Done
|
| Jun-2008 |
- FDA Warnings on Data Integrity
- Foucault's Panopticon and Compliance
- Trend Watch
- Expert: FDA's Focus on Executive Accountability
and "Grain Size"
- Leadership: Using Statistics in Decision-Making
- Book of Month: Predictably Irrational
|
| May-2008 |
- FDA Part 11 Revised
- Six Pitfalls to Avoid in Supplier Management
- Trend Watch
- Expert: Staying Compliant When You're a Small
Business or Startup
- Leadership: Mapping Key Relationships
- Book of Month: First, Break All the Rules
|
| Apr-2008 |
- Expedited Reviews and Quality by Design
- Improving Compliance in an Economic Slowdown
- Expert: Post-Market Approval Burdens
- Leadership: Leading in a Crisis
- Book of Month: Validation of Computerized Analytical and Networked Systems
|
| Mar-2008 |
- CDER and Quality by Design
- How to Protect Your Records by Really Trying
- Trend Watch
- Expert: "Silent" Medical Device Recalls
- Leadership: Getting Good Participation
- Book of Month: The Lost Art of the Great Speech
|
| Feb-2008 |
- Generic Biologics: How to Compete
- Saving Intellectual Property
- Trend Watch
- Expert: FDA Off-Label Guidance Impacts
- Leadership: Avoiding Overconfidence
- Book of Month: New Drug Development: A Regulatory Overview
|
| Jan-2008 |
- Nonclinical Data Integrity
- Annex to Q8: Quality by Design in Product Development
- Trend Watch
- Expert: Piloting Six Sigma
- Leadership: CEO Tips on Knowing When to Ask for Advice
- Book of Month: The Medical Device R&D Handbook
|
| Issue Date |
Content
|
| Dec-2007 |
- Six Tips to Better Annual Compliance Reviews
- 2007 in the Rear View Mirror: A Year-End Analysis
of Trend Watch
- Trend Watch
- Expert: Drawing the Line Between Fundamental R&D
and Product Design
- Leadership: Making the Most of Coaching
- Book of Month: Training for Dummies
|
| Nov-2007 |
- Modern Quality System Challenges
- Lean Compliance - Part 2
- Trend Watch
- Expert: When Suppliers Don't Want to Comply
- Leadership: Senior Team Morning Meetings
- Book of Month: Made to Stick
|
| Oct-2007 |
- Compliance: The Loss to Your Bottom Line (Lean
Compliance - Part 1)
- Preventing Intellectual Property Theft
- Trend Watch
- Expert: Managing IT Change Control Smoothly
- Leadership: Conflict Resolution Tips
- Book of Month: The Speed of Trust
|
| Sep-2007 |
- Postmarket FDA Surveillance: The New Rules
- Five Steps to Avoid Botching the Audit
- Trend Watch
- Expert: Nano-Particle Labeling
- Leadership: Making Better Decisions
- Book of Month: Design for Six Sigma
|
| Aug-2007 |
- Drug Safety Data - An Interview
- Roadmap for Cost-Effective Part 11 Compliance
- Trend Watch
- Expert: Pushing Back on Auditors
- Leadership: Managing a Crisis Well
- Book of Month: Sun Tzu for Execution
|
| Jul-2007 |
- Addressing Information Integrity
- Strategic Vendor Selection
- Trend Watch
- Expert: Answering Auditor Questions
- Leadership: Running an Effective Meeting
- Book of Month: Writing to Learn
|
| Jun-2007 |
- Analysis: Quality by Design
- Joint Development Agreements
- Trend Watch
- Expert: Handling Costly Computer Validation
"Solutions"
- Leadership: Effective Communication
- Book of Month: Mind Set!
|
| May-2007 |
- Continuous Improvement Components
- Financial Compliance Without Breaking the Bank
- Trend Watch
- Expert: Dealing with Anxiety Around Audits
- Leadership: Tactics to Control Costs
- Book of Month: Six Thinking Hats
|
| Apr-2007 |
- Quality as a Competitive Advantage
- Export Compliance Focus
- Trend Watch
- Expert: Hiring a Good Consultant
- Leadership: Improving Decision Impacts
- Book of Month: IT Governance
|
| Mar-2007 |
- Adapting to Global Competition
- Guest Article: Policies, Policies,
Policies
- Trend Watch
- Expert: Compliance and Your Board of Directors
- Leadership: Improving Clinical Study Approvals
- Book of Month: The Starfish and the Spider
|
| Feb-2007 |
- FDA Enforcement Trends
- Global Regulations Converge
- Trend Watch
- Expert: Drug Disposal Ruling Impacts
- Leadership: Avoiding the Minutiae
- Book of Month: Why Smart Executives Fail
|
| Jan-2007 |
- FDA Guidance Documents - A Strategic Opportunity
- Four Tips to Control Compliance Costs
- Trend Watch
- Expert: Getting FDA's Regional Office to Help
- Leadership: CEO Tips to Improve Oversight Boards
- Book of Month: Blue Ocean Strategy
|
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