Dear All,

My apologies for the slight delay in the launch of the first electronic issue of our newsletter Scribe. This was largely the result of prolonged labor that is sometimes associated with the birth of a 'new' baby. But the good news is that there is 'some evidence' that prolonged labor may be beneficial for the newborn! Budgetary and technical issues have been almost sorted out and we hope to have the next Scribe on schedule.

By the time you read this issue of Scribe it may be the last month of winter in the U.S. but it's summer in the southern hemisphere. To respect the ISPE members in the down south we have decided to do away with associating the four seasons in the northern hemisphere with the issue of Scribe. Please let us know if you have any opinion on this.

I am happy to report that this issue of Scribe has coverage of three international meetings in our field notably the National Centers annual meeting of the WHO Drug Monitoring Program held in New Delhi, India, the Sixth International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use meeting held in Osaka, Japan, and the first meeting of the WHO's advisory committee (AC) on safety of medicinal products held in Geneva, Switzerland. I am grateful to the authors of these dispatches and to those who submitted articles on other topics including a report on the reorganization of the pharmaceuticals and devices agency in Japan, the academic showcase at last year's ICPE, and the FDA Commissioner Dr. Mark McClellan's keynote speech at the FDA/PhRMA workshop on Risk Detection, Management and Communication. Our regular Scribeline column features Nicholas Moore, the chairperson of this year's Scientific Program Committee of ICPE. Please continue to send me your evaluation of this feature and as always rush your response when you receive the questionnaire.

Members may be interested to know that two FDA AC meetings that were relevant to our field took place last month. The first was held on February 2 to discuss the association of suicide and suicidal ideation with the use of the SSRI antidepressants in children. On February 26-27, another AC meeting was held to discuss the effectiveness of the risk management program (RMP) for the prevention of fetal exposure to isotretinoin and to consider whether changes to this RMP are appropriate. Details on both these meetings including briefings are available from the FDA website (www.fda.gov).

It is heartening to know that the Call of Abstracts for our annual meeting this year has resulted in the submission of over 700 abstracts — perhaps the largest number of abstracts received in the society's history! Last year the total number of abstracts received was about 400. The large number of societies who have jointly sponsored this year's ICPE is an attestation to the respect and popularity ISPE has gained over the years. Another society that could be tapped for future collaboration is the American Society for Clinical Pharmacology and Therapeutics (www.ascpt.org). This is more likely with the recent announcement of Peter Honig, MD, MPH (the former director of FDA's Office of Drug Safety, and currently with Merck) as the President-elect of ASCPT.

Let me reiterate that the success of Scribe depends on your contribution. So, please continue to send in news about any award you have won, review of any book of general interest in our field that you may have read, report from any recent meetings of general interest to the membership that you have attended, or news about personal milestones birth/weddings announcements etc.

I started my column with the announcement of the birth of electronic Scribe. Let me conclude by another birth announcement: Congratulations to our Past President Tom MacDonald who is now a father with the birth of his son Finlay!

With peace,

Rizwan
Ahmads@cder.fda.gov

PS: We would like to know your reaction to this format of Scribe, where you have to click each link to an article to read it and click again if you wish to print the article. We would be interested to know especially if you miss having a PDF version of Scribe available to read and download as in the past. It is important that I hear your likes and dislikes on this subject. Please email me your preference now. Thanks.

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