Howdy Houston?Notes from Microsoft Convergence 2012

It?s hot and humid in Houston. I wonder if it is ever not humid here. Anyway, reporting live from Microsoft Dynamics Convergence 2012 (Twitter #CONV12) this week.

The turnout is impressive, lots of people here! Yesterday was primarily the Dynamics Communities User Groups DayONE event. Bob Peskin and I had separate presentations to the Customer Relationship Management Group (Twitter #CRMUG). Bob did a presentation on upgrading CRM from v4.0 to 2011 while I did one on ?Taking Full Advantage of Dynamics CRM?, a tips and tricks presentation. Great attendance for both sessions, very lively with lots of great interaction. Look for the content and follow up repeat webinars on the CMRUG website. If you are not member yet I recommend you check them out. It?s a user group by users for users and is worth joining if you have anything to do with Dynamics CRM.

The Welcome party was a big hit at the Houston Minute Maid Park. Impressive facility and I?m sure would be great to see a game there. I won?t be able to post pictures of the event, however, people were having a great time. The band Daughtry, American Idol winners, were playing some great jams.

The Keynotes start this morning and I am looking forward to hearing from General Colin Powell for Wednesday?s keynote. He has had an impressive career and a phenomenal leader and I?m sure his session is going to be great.

Check out our Twitter feeds for up to the minute into on InfinityInfo and MikeHammons.

Add CRM to Outlook Shortcuts

At our recent Infinity i3 Event I provided a presentation on New and Hidden Features for Dynamics CRM, Recipes for Success.

We had a lot of people comment on how they get a lot of value from these types of presentations, so, I thought we would share them all in a Recipes for Success video series.

First on the menu is Adding CRM to Outlook shortcuts. This is a quick and easy little tip to save a couple clicks for getting to your most often used records and entities in Dynamics CRM. The instructions are posted first, if your prefer to just read them, or click on the video to see it in action!

  1. In Outlook (2007 or 2010), click Shortcuts in the navigation pane. image
  2. Right-click Shortcuts and click New Shortcut. image
  3. The Add to Navigation Pane window opens, simply scroll to the CRM entities and select the ones you want. image
  4. Navigate to desired CRM entity

Add now, the video?.

Adding Dynamics CRM to Outlook Shortcuts

FDA Updates Social Media Guidelines for Pharmaceutical and Medical Device Industry

 

The FDA recently announced (some) updated social media guidelines for pharmaceutical and medical device firms. The actual title of these imageguidelines are ?Guidance for Industry: Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices?.

This is still considered Draft Guidance and is an update to previously released guidance. This is, however, the first time the FDA mentions ?emerging electronic media? with specific examples related to YouTube and Twitter.

The full FDA Draft Guidance can be downloaded here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM285145.pdf

The document is fairly short (12 pages), by government standards, and I highly recommend you read the whole thing if you are responsible for sales, marketing or customer service for pharmaceuticals or medical devices.

I will point out some important bits below, particularly, related to responses as outlined in the FDA document. This is particularly important for maintaining compliance and is a great example of why CRM systems are very important for social media interactions and staying compliant with regulations.

V. RESPONDING TO NON-PUBLIC UNSOLICITED REQUESTS FOR OFF-LABEL INFORMATION DIRECTED TO DRUG OR MEDICAL DEVICE FIRMS

1. Information distributed in response to an unsolicited request should be provided only to the individual making the request directly to the firm as a private, one-on-one communication.

2.  Information distributed in response to an unsolicited request should be tailored to answer only the specific question(s) asked.

3.  Information distributed in response to an unsolicited request should be truthful, non-misleading, accurate, and balanced.

4.  Information distributed in response to an unsolicited request should be scientific in nature.

5.  Responses to unsolicited requests for information should be generated by medical or scientific personnel independent from sales or marketing departments.

6.. Information distributed in response to an unsolicited request should be accompanied by the following:

  • A copy of the FDA-required labeling, if any, for the product (e.g., FDA-approved package insert and, if the response is for a consumer, FDA-approved patient labeling or, for new animal drugs, FDA-approved client information sheet)
  • A prominent statement notifying the recipient that FDA has not approved or cleared the product as safe and effective for the use addressed in the materials provided
  • A prominent statement disclosing the indication(s) for which FDA has approved or cleared the product
  • A prominent statement providing all important safety information including, if applicable, any boxed warning for the product
  • A complete list of references for all of the information disseminated in the response (e.g., a bibliography of publications in peer-reviewed medical journals or in medical or scientific texts; citations for data on file, for summary documents, or for abstracts)

7. A firm should maintain the following records:

  • The nature of the request for information, including the name, address, and affiliation of the requestor
  • Records regarding the information provided to the requestor
  • Any follow-up inquiries or questions from the requestor

VI. RESPONDING TO PUBLIC UNSOLICITED REQUESTS FOR OFF-LABEL INFORMATION, INCLUDING THOSE ENCOUNTERED THROUGH EMERGING ELECTRONIC MEDIA BY DRUG OR MEDICAL DEVICE FIRMS

1.  If a firm chooses to respond to public unsolicited requests for off-label information, the firm should respond only when the request pertains specifically to its own named product (and is not solely about a competitor?s product).

2.  A firm?s public response to public unsolicited requests for off-label information about its named product should be limited to providing the firm?s contact information and should not include any off-label information.

  • The firm?s public response should convey that the question pertains to an unapproved or un-cleared use of the product and state that individuals can contact the medical/scientific representative or medical affairs department with the specific unsolicited request to obtain more information.
  • The firm?s public response should provide specific contact information for the medical or scientific personnel or department (e.g., e-mail address, telephone number, facsimile) so that individuals can follow up independently with the firm to obtain specific information about the off-label use of the product through a non-public, one-on-one communication.

The customer service module within Dynamics CRM is particularly well suited to helping your team monitor, respond, and document social media interactions. We have a lot experience helping companies maintain compliance with regulations using CRM. If you need help, just call or fill out the request below and let us know.

Not really my first blog post.

I decided it was about time to actually start using my domain since I have been paying for it for all these years.

This site will be a drop box of sorts for linking my various professional and personal blogs, interests, and whatever else I decide to post here.

If you have an interest in CRM, Office 365, SharePoint, Business Intelligence (or Analytics if you prefer) and Mobility related stuff, then I encourage you to check some of my links, or just stick around here where I’ll cross post things from all of my sites.