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Yakugai History (History of Drug Disasters)

The historical events that built modern drug regulation — from Sulfanilamide (1937) to Thalidomide (1957-1962).

Drug Disaster History (chapter top)
1 Elixir Sulfanilamide — The Starting Point of Modern Drug Regulation
2 Thalidomide 1957–1962 / Worldwide — The Disaster That Built Modern Drug Regulation
3 DES (Diethylstilbestrol) — A Drug Disaster Across Generations
4 The SMON Incident — Birth of Japan's Post-Marketing Surveillance
5 HIV-Tainted Blood Products in Japan — Systemic Non-Action and Its Aftermath
6 The Drug-induced Hepatitis C Incident — Records Held but Not Used
7 Creutzfeldt–Jakob Disease from Cadaveric Dura Mater
8 Iressa (Gefitinib) — A "Miracle Drug" and Interstitial Pneumonia
9 Vioxx (Rofecoxib) — The Ethics of Data Disclosure
10 The Opioid Crisis — A Drug Disaster Not Yet Over

Ethics

Medical, corporate, and professional ethics — centered on the protection of patient rights.

Ethics (chapter top)
1 Pharmaceutical Corporate Ethics — Holding the Tension Between Profit and Medicine
2 From Nuremberg to Helsinki — The Events and Documents That Built Bioethics
3 Medical Ethics — Four Principles and the Three at the Bedside
4 If My Wife Were the Patient — Reading Patient Rights as a Stakeholder
5 Personal Professional Ethics — When Rules and Judgment Diverge
6 What is Ethics, in the First Place? — The "wrong-coffee" incident at Cafe Socrates
7 Research Ethics: History and Present — How Participant Protection Was Institutionalized
8 Publication Ethics: History and Present — The Conscience Mechanism Science Built for Itself

Compliance

The specificity of the life-related industry, and the architecture of social trust.

Compliance (chapter top)
1 Starting from "Life-Related Industry" — Reading the Walls Between Us and Patients
2 Social Trust — The Condition for This Industry to Exist
3 Corporate Philosophy — Putting Trust into Words
4 Policies — From Principle to Direction
5 SOPs — From Policy to Procedure
6 Ethics and Norms — The Undocumented Territory

Ad Regulations

Pharmaceutical advertising regulation centered on Pharmaceutical Act §§66-68.

Advertising Regulation (chapter top)
01 Pharmaceutical Act §§66-68 and the Two Cases That Shaped the Norms
02 The Suspecting Eye — Reading Risk Beyond the Rules
03 Advertising Appropriateness Standards — Operationalizing Article 66
04 MSA Guidelines — 4-chapter commentary
05 MSA Q&A commentary — 80 questions across 4 MHLW compendia
06 JPMA Code of Practice
07 JPMA Material-Creation Guide — 5-level commentary

Material Review — 8-part / 29-volume series

The work of judging promotional materials, walked through: map → international lens → mindset → solitude → risk → reasoning → per-medium practice → culture.

Material Review (index)
Vol 01 Getting to the Essence
Vol 02 Reading the Five-Layer Net
Vol 03 Efficacy Within the Approved Scope
Overseas 01 USA — Inside FDA OPDPNEW
Overseas 02 Europe — EFPIA and Layered National RegulationsNEW
Overseas 03 Asia-Pacific + Japan in ParallelNEW

Production Quality ManagementNEW

Quality assurance for client-commissioned materials — full regulatory conformance / AI review / QC-QA SOPs / four-signature delivery.

Production Quality Management (chapter)

Material Requester (Manager)'s ResponsibilitiesNEW

The intermediate gate before vendor deliverables get forwarded to internal material review.

Material Requester (Manager)'s Responsibilities (chapter)

Developing Material Creators ── Learning from Past IncidentsNEW

Drawn from 7 years and 186 deviation cases, the recurring errors in material creation structured into nine categories, read from primary sources.

Developing Material Creators (Index)
Overview ── The Whole Picture
Learning from Past Incidents (Series Index)
01 ── Data Misuse and Manipulation That Risk Factual Misrepresentation
02 ── Selective Data Extraction, Manipulation, and Presentation
03 ── Claims Without Evidence / Unreliable Data
04 ── Presenting Unapproved Indications and Dosage Regimens
05 ── Exaggerated Claims
06 ── Efficacy-Only Promotion / Safety Information Neglect
07 ── Disparagement of Competing Products
08 ── COI Non-Disclosure
09 ── Other Improper Sales Practices

Developing Material Creators ── Inside the Creator ── The Psychology Behind DeviationsNEW

How well-intentioned creators drift toward deviation under pressure — confirmation bias, motivated reasoning, local rationalization, omission, externalized responsibility — across ten chapters of psychology and organizational structure.

Inside the Creator ── The Psychology Behind Deviations (Series Index)
01 ── A Map of Pressure — How Good Intentions Bend
02 ── The Creed Trap — "I Want to Help Patients" as the Entry Point
03 ── Conclusion First, Data Second — Motivated Reasoning
04 ── "Just One Slide" — Local Rationalization
05 ── The Choice Not to Speak — The Sin of Omission
06 ── Structures That Let You Blame Someone Else — Externalizing Responsibility
07 ── The Gravity of Numbers — Quotas and the Psychology of Incentives
08 ── The Anxiety of Competition — How Panic Becomes Disparagement
09 ── The Silent Organization — Conformity Pressure, Hollow Audits, and the Self That Won't Disclose
10 ── Redesigning Pressure — Individual Psychology and Organizational Systems

Developing Material Creators ── As We Should Be ── Ten Convictions for Material CreatorsNEW

Who a material creator should be — ten convictions articulating the professional backbone that prevents deviation: standing as an evidence steward rather than a salesperson, responsibility for the reader's mental image, a conscience led by data, signing the whole document, and a duty to present efficacy and safety on equal footing. Ten chapters.

As We Should Be ── Ten Convictions for Material Creators (Series Index)
01 ── Scientific Evidence Steward — I Am Not a Salesperson
02 ── Taking Responsibility for the Reader's Mental Image
03 ── The Conscience That Doubts Conclusions — Led by Data
04 ── Sign the Whole — Not Just One Slide
05 ── Duty to Tell — Efficacy and Safety on Equal Footing
06 ── Own It — Don't Hide Behind "The Physician Decides"
07 ── The Right Distance from Numbers — Quotas as Constraints, Not Goals
08 ── Respect for Competitors — Fair Play Builds Trust
09 ── Staying Open — Disclosing Limitations, Uncertainty, and Conflicts of Interest on Your Own
10 ── Embedding Conscience into the Organization's Systems — From the Individual to the Organization, Made Visible

Reviewer Development ── The Compound Eye of ReviewNEW

Reading deviations that clause-matching alone cannot catch, from the standpoints of patients, families, lawyers, regulators, and society. Ten chapters move between the rule-eye that reads the rules closely and the recipient-eye, and show how to hold both together.

The Compound Eye of Review (Series Index)
01 ── Two Ways of Seeing — Why Reviewers Need Both the Rule-Eye and the Recipient-Eye
02 ── Micro-Level Reading — Knowing the Rules, and Why They Exist
03 ── Someone Is on the Other Side of My Reviewing Eye — Perspective-Taking as a Way of Using Knowledge
04 ── The Patient's Eye — I Am the One Who Takes This Drug
05 ── The Family's Eye — Spouse, Parent, Adult Child at the Bedside
06 ── The Lawyer's Eye — Can This Material Survive Cross-Examination?
07 ── The Regulator's Eye — Reading Your Own Materials from the Inspection Standpoint
08 ── Imagining the Front-Page Headline — The Most Critical Eye: Media and Society
09 ── Integrating Lenses — What Premortem and Bird's-Eye View Add to Material Review
10 ── Making the bird's-eye view a habit — reading past failures as a mirror

Perspectives ── The Four Layers of Management ── 5 series × 10 episodes = 50 vol

The manager's view broken into five layers — capital (the capitalist), governance (the board), execution (the executives), risk, and the foreign-pharma president — reading what material review means in the language of management.

The Four Layers of Management (hub)
The Capitalist's View — Investment and Profit (index)
The Capitalist's View — Investment and Profit — Vol. 1
The Capitalist's View — Investment and Profit — Vol. 2
The Capitalist's View — Investment and Profit — Vol. 3
The Capitalist's View — Investment and Profit — Vol. 4
The Capitalist's View — Investment and Profit — Vol. 5
The Capitalist's View — Investment and Profit — Vol. 6
The Capitalist's View — Investment and Profit — Vol. 7
The Capitalist's View — Investment and Profit — Vol. 8
The Capitalist's View — Investment and Profit — Vol. 9
The Capitalist's View — Investment and Profit — Vol. 10
The Board's View — Corporate Governance (index)
The Board's View — Corporate Governance — Vol. 1
The Board's View — Corporate Governance — Vol. 2
The Board's View — Corporate Governance — Vol. 3
The Board's View — Corporate Governance — Vol. 4
The Board's View — Corporate Governance — Vol. 5
The Board's View — Corporate Governance — Vol. 6
The Board's View — Corporate Governance — Vol. 7
The Board's View — Corporate Governance — Vol. 8
The Board's View — Corporate Governance — Vol. 9
The Board's View — Corporate Governance — Vol. 10
The Executives' View — Running the Business (index)
The Executives' View — Running the Business — Vol. 1
The Executives' View — Running the Business — Vol. 2
The Executives' View — Running the Business — Vol. 3
The Executives' View — Running the Business — Vol. 4
The Executives' View — Running the Business — Vol. 5
The Executives' View — Running the Business — Vol. 6
The Executives' View — Running the Business — Vol. 7
The Executives' View — Running the Business — Vol. 8
The Executives' View — Running the Business — Vol. 9
The Executives' View — Running the Business — Vol. 10
Management and Risk (index)
Management and Risk — Vol. 1
Management and Risk — Vol. 2
Management and Risk — Vol. 3
Management and Risk — Vol. 4
Management and Risk — Vol. 5
Management and Risk — Vol. 6
Management and Risk — Vol. 7
Management and Risk — Vol. 8
Management and Risk — Vol. 9
Management and Risk — Vol. 10

Perspectives ── Metacognition (Introspection) ── 3 series × 10 episodes = 30 vol

"Looking at the self" — introspection and awareness series. From Freud / Jung / Adler to Baumeister / Bandura / Neff.

Mind Mirror (index)
Self-Understanding — Looking into the Mirror (10 episodes)
Recognizing Overconfidence — Metacognition, Dunning-Kruger (10 episodes)
Self-Affirmation & Self-Criticism — Positive Psychology, Self-Efficacy, Self-Compassion (1 published + 9 coming soon)

Perspectives ── Self-Transformation ── 2 series × 10 episodes = 20 vol

"Changing the inner self" — transformation and confidence series. Acceptance, change, and self-efficacy.

Self-Transformation — Acceptance + Change (10 episodes)
Confidence — Self-Efficacy and Practical Confidence (10 episodes)

Perspectives ── Communication ── 10 episodes

Dialogue with others, correctness vs. reach, feedback delivery, the option of silence.

Communication — Correctness vs. Reach (10 episodes)

AI Courses (Basics)

Practical fundamentals for using AI in daily work.

AI Courses (Applied)

AI in marketing, programming, and healthcare.

AI and Emerging Technology

Industry models, companies, R&D, regulatory dynamics.

Column

Daily notes and reflections.

Column (index)

Other

AI and the Pharmaceutical IndustryNEW

Daily record of pharmaceutical AI funding, deals and deployments across 15 business functions, from drug discovery to finance.

AI Economy & FinanceNEW

Twice-daily reports on AI and the economy, and AI and finance, in the same format as AI Daily News.

AI Daily Update VideoNEW

A fifteen-minute explainer on the day's AI, with full transcript and sources.

Microsoft Copilot Know-howNEW

Sourced know-how for Microsoft 365 Copilot: 10 app pages and 6 cross-cutting topics.

Microsoft Copilot AdvancedNEW

Combining Microsoft 365 apps with Python, Microsoft Graph and automation: 10 app pages and 6 thinking-and-method pages, with code, permissions, test results and sources.

AI LiteracyNEW

Eleven stages of working with AI, from a first spark to running it, in 10 series of 10 episodes. One a day.

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