{"id":4840,"date":"2025-08-05T18:58:28","date_gmt":"2025-08-06T00:58:28","guid":{"rendered":"https:\/\/allphasepharma.com\/dir\/?p=4840"},"modified":"2025-08-05T18:58:33","modified_gmt":"2025-08-06T00:58:33","slug":"regulatory-interactions-2-the-kata-of-proper-behavior","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2025\/08\/05\/4840\/regulatory-interactions-2-the-kata-of-proper-behavior\/","title":{"rendered":"REGULATORY INTERACTIONS\u00a0– 2 The “KATA” of Proper Behavior"},"content":{"rendered":"\n
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Language-related issues come up quite frequently.  Most interactions with regulators are held in English, but not all of them.  In China, it is Mandarin, and in Japan it is, well, Japanese.  In Europe, it is mostly English, but French and German occasionally creeps into the dialogue.  In China, even if regulators understand English well, they often feel uncomfortable expressing themselves in a foreign language.  In Europe English is the lingua franca, of course.<\/p>\n\n\n\n

Language is deeply connected with culture and conveys so much more than any literal translation can provide.  Misunderstandings because of language barriers and misinterpretation because of cultural barriers still occur very, very often.  Initially misunderstandings lead to confusion but may end up in argumentative exchanges.<\/p>\n\n\n\n

Of course, native speakers from the company with good English skills will be at the meeting.  For meetings in Asian countries, it is advisable to engage simultaneous translation services.  These are highly specialized people with unique skills comfortable with the medical science vocabulary. <\/p>\n\n\n\n

It is the Q&A session when things get tricky. A wrong word or poorly phrased statement may trigger a verbal back and forth ending in confrontational posturing or even heated exchange. <\/p>\n\n\n\n

Take the situation of a high-level company executive who started arguing with Regulators at a face-to-face meeting, raising his voice, insisting on his point of view.  Other than making everyone uncomfortable, this created quite an adversarial atmosphere which lasted for the entire session. <\/p>\n\n\n\n

Defending your case with the authorities is fine, but it has to be done respectfully, carefully, and in a culturally acceptable way.  When disagreements surface, they need to be handled unemotionally as a measured response. <\/p>\n\n\n\n

Situational awareness is key.  Company boardroom behavior is not appropriate to further your case with Regulators.  Avoid coming over as pushy or condescending.  Exclude persons who have an unchecked temper, regardless of hierarchy.  Don\u2019t get carried away and start lecturing regulators on medicine or dazzle them with your superior subject matter expertise.  They are not your students. When corrections need to be made, they should be stated in a non-confrontational way.  <\/p>\n\n\n\n

Try to avoid any back and forth rapid-fire exchanges as this is not a card game, and you don\u2019t hold all the trump cards.  Nothing is gained by a series of argumentative exchanges as this leads to further friction, wasting valuable time.  You certainly do not want anyone to lose face. <\/p>\n\n\n\n

Consider this example of cultural insensitivity and general bad behavior.  A corporate leader being British and certainly able to express himself well, raises his voice arguing with Chinese regulators, who respond by simply reaffirming their position in frosty confrontation. <\/p>\n\n\n\n

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Take away lesson: Your goal is a smooth regulatory interaction leading to mutual agreement on development path or labeling issues, whatever the case may be.  Unhinged behavior is counterproductive.<\/p>\n\n\n\n

\n

Pharma is a regulated industry\u2013 and being on the receiving end, it behooves us to tread carefully.\u00a0<\/em><\/p>\n<\/blockquote>\n\n\n\n

All this is common sense, so why are we talking about it here so much?  Because faux-pas are too frequent in encounters with Regulators. Lack of international experience and\/or lack of exposure to foreign cultures is probably the main reason.  Of course, mistakes are made under stress.  Trying to meet expectations, managing a complex interaction while being on top of the data, keeping cool under pressure is not everyone\u2019s cup of tea.<\/p>\n\n\n\n

Under stress many regress to a lower level of function and revert to entrenched behavior.  We don\u2019t want to stereotype, but many corporate leaders are culturally insensitive. For example, Americans are known for speaking too much and too forcefully while not listening enough.  Brits also are known for having a high brow and not handling cultural diversity well. This can become problematic in exchanges as foreigners cannot be expected to process information as fast as native language speakers communicate. <\/p>\n\n\n\n

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In Japan, Regulators hardly ever interject during a presentation. Their discussion is mainly with carefully selected KOLs, from the company and their own appointed experts, and everything will be held in Japanese.  It is considered disrespectful to interrupt; therefore, procedural matters (who presents and who handles the Q&A sessions) will need to be rehearsed carefully beforehand, because during the actual meeting, company representatives only have a supporting role.  In Japan, everything follows a \u2018Kata\u2019 as described so well in the book referenced below.[1]<\/a><\/p>\n\n\n\n

\u2018Kata\u2019 refers to the proper way of doing things in all of life\u2019s situations, especially in personal interactions.  There is a lot of \u2018Kata\u2019 behavior that should be observed in regulatory interactions.  A good understanding of the \u2018Rules of engagement\u2019 helps if things are to run smoothly.<\/p>\n\n\n\n

Surprises, good and bad, are fairly common in regulatory interactions, so it behooves us to be prepared for these eventualities.  Handling the unexpected in a professional and balanced fashion is best in the long run.  It\u2019s an art in which diplomates excel, company execs less so.<\/p>\n\n\n\n

\n

When an expert selected by the Agency went off-track stating some very excentric views, everyone felt embarrassed.  While it may be hard to ignore at first blush, one better handles unqualified remarks with silence or mild correction, and moves on. <\/em><\/p>\n<\/blockquote>\n\n\n\n

\n

A reviewer started a meeting informing everyone that there was no medical need for the compound under review. Oh man, that felt like a low kick to the stomach. Strangely enough, the remark was totally ignored as the session proceeded. It was wise not to start a lengthy rebuttal.<\/em><\/p>\n<\/blockquote>\n\n\n\n

We did not mention European regulators so far.  With fewer language or cultural issues to contend with, these interactions tend to be easier linguistically and culturally.  The Q&A usually involves all the panelists; clarification of project details is followed by a discussion about applicable guidances and the framework of regulatory precedent.  Then the Agency, be it EMA or PEI,<\/p>\n\n\n\n

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\"\"<\/a><\/figure>\n\n\n\n

may discuss next steps making recommendations. There is some truth to the rumor that French AFSAPS meetings had a reputation for expressing strong opinions that differ in unpredictable inexplicable ways from recommendation by other Agencies, but maybe this is now pass\u00e9 at the newly formed ANSM. <\/p>\n\n\n\n

\"\"<\/a><\/figure>\n\n\n\n

Handling curveballs and harmonizing diverging recommendations can become a high-wire act.  Some Health Authority responses can be flat-out wrong, and their recommendations need to be ignored for the moment to be followed up at subsequent meetings. Remember, not every Agency has all the resources and the best experts. We recall several instances during which Agency reviewers demonstrated egregious lack of subject-matter expertise.<\/p>\n\n\n\n

Much can learned at meetings with Regulators.  Let\u2019s admit that Regulators have probably seen similar submissions before. They also have analyzed more dossiers than anyone on your team having come across toxicities that were never published and which by law they are not allowed to divulge. However, they can provide hints and point out areas of concern not fully appreciated by your team. These hints can be really helpful during development, especially at the early stages of an NCE. Body language, emphasis and choice of words go beyond the spoken word. To capture this, language proficiency is key.  Also, cultural awareness will help greatly to interprete cues correctly. <\/p>\n\n\n\n

Otherwise, much might get lost in translation.<\/p>\n\n\n\n

\n\n\n\n

REFERENCES<\/strong>
[1]<\/a> Lafayette de Mente B.  Kata: The Key to Understanding & Dealing with the Japanese!  Tuttle Publishing 2003<\/p>\n\n\n\n

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<\/p>\n","protected":false},"excerpt":{"rendered":"

Language-related issues come up quite frequently.  Most interactions with regulators are held in English, but not all of them.  In China, it is Mandarin, and in Japan it is, well, Japanese.  In Europe, it is mostly English, but French and German occasionally creeps into the dialogue.  In China, even if Continue reading REGULATORY INTERACTIONS\u00a0– 2 The “KATA” of Proper Behavior<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":4841,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[140,3,18],"tags":[2346,1271,2314,2349,625,5,1583,2312,2347,2351,2315,2054,2317,2318,2350,2310,2313,2348],"class_list":["post-4840","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-interesting_facts","category-the_news","category-the_viewpoint","tag-afssaps","tag-allphase-pharma-consulting","tag-cde","tag-cultural-sensitivity","tag-ema","tag-fda","tag-harald-reinhart","tag-health-canada","tag-kata","tag-language-issues","tag-nmpa","tag-pmda","tag-regional-regulatory-differences","tag-regulatory-meeting-preparation","tag-situational-awareness","tag-swissmedic","tag-tga","tag-the-proper-way-to-behave"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2025\/08\/HR_SLIDER-REGULATORY-2.jpg?fit=640%2C180&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-1g4","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":4672,"url":"https:\/\/allphasepharma.com\/dir\/2025\/07\/06\/4672\/regulatory-interactions-1\/","url_meta":{"origin":4840,"position":0},"title":"REGULATORY INTERACTIONS \u00a0– 1","author":"Harald","date":"July 6, 2025","format":false,"excerpt":"It can feel like the mountain stage of the Tour de France\u2026 A lot of effort goes into preparing for meetings with Regulators.\u00a0 There is also a lot we can learn at such meetings. 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The original NDA for dalbavancin was submitted to FDA on Dec. 21, 2004.\u00a0 Pfizer acquired dalbavancin\u00a0as a \u201cPhase 3 completed\u201d drug ready for world-wide marketing on June 15, 2005. 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