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ISPE’s Regulatory Commenting Process

ISPE

ISPE’s Regulatory Commenting Process Trudy Patterson Tue, 02/14/2023 - 16:19 iSpeak Blog iSpeak ISPE’s Regulatory Commenting Process Wendy McGhee 14 February 2023 What is Commenting? ISPE submits official comments when we are able to provide that input. What is Commenting? How Does It Work? Know the key topics.

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First-of-a-kind psoriasis study outcomes revealed

European Pharmaceutical Review

It is the first prospective, large-scale, randomised-controlled clinical trial evaluating people of colour across all skin tones with moderate to severe plaque PsO and scalp PsO to objectively measure clearance and other treatment outcomes with Tremfya.

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Takeda halts trial of orexin drug in narcolepsy on safety grounds

pharmaphorum

The orally-active drug was granted breakthrough status by the FDA in August for treating type 1 narcolepsy, a form where the sleep symptoms are accompanied by a sudden loss of voluntary control tone known as cataplexy. The post Takeda halts trial of orexin drug in narcolepsy on safety grounds appeared first on.

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13th PM Society Digital Awards – celebrating creative innovation

pharmaphorum

As a spokesperson for the PM Society commented, “We were very cognisant and respectful of events unfolding beyond the awards, but after much consideration and speaking with attendees, we decided to go ahead and we’re so glad that we did.

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Create a Kick-ass Social Media Strategy for Your Independent Pharmacy

DiversifyRx

Actively engage with your audience through comments and discussions. The algorithms will recognize these comments as signals that you have a real relationship with them and show them more of your content in their feed. Yes, respond to all your comments, good or bad. Focus on including the keywords you want to be ranked for.

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GAMP 5 update: computerized system expectations for pharma manufacturers

European Pharmaceutical Review

Arbitrary comments, excessive evidence gathering, and non-focused testing are roundly rejected by ISPE GAMP 5 Second Edition.” Arbitrary comments, excessive evidence gathering, and non-focused testing are roundly rejected by ISPE GAMP 5 Second Edition.

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How to break difficult news with respect

pharmaphorum

Set the appropriate tone. Don’t try to emulate an optimistic tone if that feels inadequate. Be sure to adopt a business-like tone and appropriate degree of formality; even if you’ve known people for years and consider them friends, its vital to stay professional when having difficult conversations. Closing the meeting.