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Ask Me Anything Session Wednesday 12 December at 1:30 PM EST

  • 1.  Ask Me Anything Session Wednesday 12 December at 1:30 PM EST

    Posted 05-Dec-2018 09:10

    Hi RegEx Members,

    Mark your calendars: as part of the Quarterly Regulatory Focus article series, we will be hosting an Ask Me Anything Session next Wednesday 12 December, from 1:30 PM- 2:30 PM EST  here on RegEx. This series focuses on current trends and best practices in Global Advertising, Promotion and Labeling (APL) Regulations. Five APL experts, Linda Politz, Julie Batel, Richard Lem, Georgina Lee and John Wong, will be available to discuss the latest issues and answer your questions in real time. 

    Can't make the session? No worries-the full discussion will be available on RegEx afterward. Also, feel free to submit your questions beforehand by replying to this thread or by sending me an email at regex@raps.org.

    Looking forward to seeing your questions and to a great discussion next week!

     

    Best,

    Emily

     



    ------------------------------
    Emily Stamm
    Community Manager
    Regulatory Affairs Professionals Society®
    regex@raps.org
    ------------------------------


  • 2.  RE: Ask Me Anything Session Wednesday 12 December at 1:30 PM EST

    Posted 05-Dec-2018 14:51
    Hi RegEx, I am excited to speak with the other experts and answer your questions. I hope you can join us next Wednesday! A little about me - I am the head of Regulatory Affairs - Advertising, Promotion and Labeling at Agios and have been in the industry for close to 7 years, mainly in Neurology and Oncology. I look forward to speaking with you all soon!

    ------------------------------
    Georgina Lee PharmD
    Cambridge MA
    United States
    ------------------------------

    Original Message


  • 3.  RE: Ask Me Anything Session Wednesday 12 December at 1:30 PM EST

    Posted 05-Dec-2018 15:37
    ​Hi RedEx Members.
    I hope you'll be able to join this discussion. I'll be on the panel as well. A little about me: I am current Senior Director Regulatory Affairs, Advertising & Promotion, at Alkermes. I've been in Regulatory since 1995, and focusing on advertising & promotion since 2001. Needless to say, I've seen and experienced a lot over the years! I'm excited for all of you to submit your questions and join in the dialog next week!
    Best,
    Linda Pollitz

    ------------------------------
    Linda Pollitz RAC
    Senior Director, Regulatory Affairs, Advertising & Promotion
    Alkermes, Inc.
    Waltham, MA
    United States
    ------------------------------

    Original Message


  • 4.  RE: Ask Me Anything Session Wednesday 12 December at 1:30 PM EST

    This message was posted by a user wishing to remain anonymous
    Posted 06-Dec-2018 09:19
    This message was posted by a user wishing to remain anonymous

    Dear All,
    this is a great event and since I won't be able to attend, I'd like to ask my question this way..

    We are manufacturing a device that is made of both resorbable and non-resorbable materials. We used to call this 'partially resorbable' and market the device as such in the EU. After several years of marketing the device in EU, we are submitting the device for clearance in the US process and FDA found fault with the term of partial resorbability and want us to remove any such statements. As there is a non-resorbable component, we are fine with adjusting our labeling accordingly, but marketing wants to keep the term 'partially resorbable' for non-US markets.
    If we follow marketing's wish, this would result in us labeling/advertising the device differently in different countries - could this get us into trouble, i.e. would we have to adjust all labeling and marketing materials worldwide?

    Many thanks!
    Original Message


  • 5.  RE: Ask Me Anything Session Wednesday 12 December at 1:30 PM EST

    This message was posted by a user wishing to remain anonymous
    Posted 06-Dec-2018 10:16
    This message was posted by a user wishing to remain anonymous

    I think this session will be highly helpful. Couple of questions:  

    - Do disease awareness informational pieces, newsletters etc., need to be submitted on 2253?

     

    - What if the disease awareness piece mentions the drug or has the logo of the company and the drug - still acceptable to NOT submit on 2253?
    Original Message


  • 6.  RE: Ask Me Anything Session Wednesday 12 December at 1:30 PM EST

    Posted 06-Dec-2018 11:07
    ​Hi RegEx Community!

    I hope you'll be able to join us as we discuss various topics relating to advertising, promotion, and labeling regulations.

    I am an Associate Director in the Regulatory Affairs Advertising and Promotion group at Bayer. I've been in the industry for 6 years, predominately in the advertising and promotion space, and my areas of focus are in Neurology, Hematology, and Oncology. Most recently, my experience has been focused on launching accelerated approval products in the rare disease space.

    Look forward to meeting everyone next week!

    ------------------------------
    Richard Lem, PharmD
    Whippany, NJ
    United States
    ------------------------------

    Original Message


  • 7.  RE: Ask Me Anything Session Wednesday 12 December at 1:30 PM EST

    Posted 06-Dec-2018 12:56
    Hi RegEx members,

    Looking forward to be part of this group of experts panel.  I will be bringing some insights from the Canadian perspective for drug advertising & promotion.I am currently the Director, Regulatory Drug Advertising & Promotion at TPIreg/ Innomar Strategies. I was formerly the Deputy Commissioner at the PAAB. Some of you may have heard of PAAB, it is the Pharmaceutical Advertising Advisory Board, the national regulatory body for the preclearance of prescription drug advertising in Canada. If you are planning any marketing activities in Canada or launching a new drug soon, I'll be happy to discuss further at our session.

    Chat soon,

    John

    ------------------------------
    John Wong
    Director Regulatory Drug Advertising & Promotion
    Oakville ON
    Canada
    ------------------------------

    Original Message


  • 8.  RE: Ask Me Anything Session Wednesday 12 December at 1:30 PM EST

    Posted 09-Dec-2018 17:04
    ​I am looking forward to the discussion on Wednesday. To provide a bit of context, I have been the Head of Regulatory Labeling  at Shire for the past 3 years. Prior to that I was the Head of Global Labeling at Takeda. I have been working in pharmaceutical regulatory affairs since 2002 when I joined Millennium in the Regulatory CMC organization. I am looking forward to some interesting questions. Labeling, Advertising and  Promotion provide lots of material!

    ------------------------------
    Julie Batal
    VP, Head of Regulatory Labeling
    Shire
    Cambridge, MA USA
    ------------------------------

    Original Message


  • 9.  RE: Ask Me Anything Session Wednesday 12 December at 1:30 PM EST

    This message was posted by a user wishing to remain anonymous
    Posted 12-Dec-2018 12:26
    This message was posted by a user wishing to remain anonymous

    HI, I have a question for the discussion- 
    my company has a tag line we use, that has a footnote to it. 
    example: 
    Company A
    the #1 provider of drug type - with a foot noted reference.

    When we do promotional materials with the tag line, we always include the footnote and reference.
    However, the  marketing team wants to ​put the Company name and tag line on the front of a tablecloth to be used at displays at conferences and such. 
    it will be just the name and tag line, no product info on the cloth itself. 
    All the related materials have the reference. the question is, do we need to have the footnote on the tablecloth, and if so, where does the reference info need to be in order to remain compliant? 

    thanks so much for your input! we are a very small company, which is why I wanted to post this anonymously.
    Original Message


  • 10.  RE: Ask Me Anything Session Wednesday 12 December at 1:30 PM EST

    Posted 12-Dec-2018 13:15
    Can you provide some more context? For example, is that tablecloth with tagline to be used in a branded conference booth? Will it just be used in a corporate booth?

    ------------------------------
    Linda Pollitz RAC
    Senior Director, Regulatory Affairs, Advertising & Promotion
    Bedford MA
    United States
    ------------------------------

    Original Message


  • 11.  RE: Ask Me Anything Session Wednesday 12 December at 1:30 PM EST

    Posted 12-Dec-2018 13:17
    Additionally, can you clarify what the footnote includes above and beyond the reference, or whether the footnote is the reference itself?

    ------------------------------
    Richard Lem
    Whippany NJ
    United States
    ------------------------------

    Original Message


  • 12.  RE: Ask Me Anything Session Wednesday 12 December at 1:30 PM EST

    This message was posted by a user wishing to remain anonymous
    Posted 12-Dec-2018 14:02
    This message was posted by a user wishing to remain anonymous

    thanks for your follow up questions- 
    The table cloth will be used at a corporate conference booth, that will have information about the company and the products we sell. 
    The footnote is simply the number 1, and then the reference information (usually in the footnote references at the bottom of the promotional piece) states "Data on file, IMS data 2017"

    thank you!
    Original Message


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