GENERAL PROGRAMME GUIDELINES/SUPPORTED SPEAKERS/REGULATORY AGENCY SPEAKERS
Below are general guidelines to be followed within each session:
- Co-chairs or co-presenters for presentations are not encouraged.
- More than one participant from the same company in session is not permitted. No exceptions will be made.
- Chairperson must ensure good representation/diversity in the selection of speakers/panelists. If applicable, government, academia, CSO, and/or industry perspectives should be represented.
- Review session summaries.
- No internet connectivity is available in the session room.
- Each session is limited to one supported participant (see Speaker Support below).
- Programme participants are responsible for their own travel/hotel expenses (unless they qualify for support – see Speaker Support below).
- DIA meetings will be educational, not commercial and promotional. All speakers must ensure that their presentation is not of a commercial or promotional nature, and that logos and company information are only included on the first page of the PowerPoint presentation and printed materials. In addition, speaker clothing may not carry logs or other company-specific emblems. All participants must follow the DIA Policy Concerning Promotion of Products and Services from the Podium.
Each session is limited to a maximum of one supported participant. Supported speakers include full-time government/regulatory and academic employees and patient advocates. All requests for support must be sent to the DIA Europe office for approval before chairs/speakers/panelists are invited and before the programme is developed.
Regulatory Agency Speakers:
Supported speakers will receive round-trip economy airfare (arranged through the DIA travel agent), plus hotel room and tax for a number of hotel nights corresponding to their involvement in the programme. Any additional miscellaneous expenses must be agreed with DIA in advance and may be reimbursed up to EUR 50 per day. Receipts must be submitted at time of reimbursement.
Meeting registration fee is waived for confirmed speakers.
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- Individuals from the following regulatory organisations may not be contacted directly to participate: FDA, EMA, European Commission, MHRA, SFDA, and Health Canada. Per regulatory agency policy, DIA is to officially request the participation of speakers from these organisations. The chair is to provide DIA with the requested speaker’s name and topic to be presented as early as possible to ensure the best opportunity for receiving approval from the respective agency.
- Speakers from other organisations not indicated above may be contacted directly by the session chair.
- Meeting registration fee is waived for confirmed regulatory agency speakers.
HELPFUL HINTS FOR A SUCCESSFUL PROGRAMME PARTICIPANT EXPERIENCE
Promotion at the Podium:
- All presentations must be fair, balanced and free of commercial bias.
- Presentation must not be commercial or promotional
- Company (including consultants and institution) logo may appear only on slide 1.
- Speaker clothing may not carry logos or other company specific emblems.
During the Session:
- Project your voice and speak clearly. Lectern microphone should be placed hands width away and just below your mouth. Face your audience and avoid turning your head away from the microphone.
- Repeat questions that were asked without the use of a microphone.
- Turn off cell phones/tablets during the session.
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- Start activity on time. Request to have cell phones and blackberries disabled.
- Ensure the audience can hear your speakers.
- Remind any speaker or attendee not using the microphone effectively to move closer or reposition the microphone.
- Provide adequate time for audience question & answer time.
- Finish on time.
STANDARD ROOM SETUP/AV EQUIPMENT
Standard Meeting Room:
- (1) Screen
- (1) Projector
- (1) Lectern
- (1) Laptop*
- (1) Head table/dais, 4 chairs
- (2) Table microphones
- (1-2) Floor microphones
- (1) Lapel microphone
Note: Internet connectivity is not guaranteed
*All presentations will be pre-loaded to laptop on lectern. Laptop has software for audio-synchronisation with PowerPoint slides.
- All presentations are to be fair balanced and free of commercial bias.
- All programme participants in a position to control content (this includes programme chairperson and committee members, theme leaders, session chairs, speakers, and panelists) must provide DIA with any significant financial relationships they have with the manufacturer of products or services as discussed within their presentation or with regard to the content of the session/meeting (for those who are not speaking).*
- If a programme participant (as noted above) has a conflict of interest as a result of the financial relationship, this will need to be resolved prior to the meeting.
- If a programme participant does not provide disclosure to DIA, he/she will not be permitted to participate in the meeting.
- When discussing therapeutic options, it is DIA’s preference that only generic names and not trade names be used. If it is necessary to use trade names, please use the trade names of all products being discussed.
DISCLOSURE Q & A
Why do volunteers need to disclose? As an accredited provider DIA is required to provide its activity participants with any conflict of interest a programme participant may have.
Who needs to disclose? Anyone in a position to control content: Programme chairperson(s), Track chairs, Session chairs, Speakers, Panelists, Authors, DIA staff developing content. (The above are referred to in this document as programmeme participants)
What needs to be disclosed? All relevant financial relationships between the commercial supporter (if applicable) or manufacturer of services discussed within the activity and/or presentation. Programme chairpersons and track chairs need to provide disclosure related to the development of the activity; session chairs, speakers, and authors need to provide disclosure related to the content of their presentation. If a programme participant has no financial relationships, that also needs to be disclosed.
Does a programme participant need to disclose all financial relationships? No, only those that pertain to the content of the educational activity or presentation.
Does a programme participant need to disclose the amount of the financial relationship? No.
If a volunteer participates as a programme participant in multiple activities, does he/she have to complete a disclosure form for each activity? Yes. The disclosure is pertinent to the content/presentation of the given activity.
If a programme participant has a conflict of interest, the conflict must be addressed prior to the educational activity. If resolution cannot be made, CME credit may or may not be offered for the activity.
The Drug Information Association encourages and supports the exchange and dissemination of information pertaining to research and development of health care products, regulatory processes, emerging technologies, and information management. The Association does this by providing its members a neutral forum for education and discussion opportunities concerning the latest technologies and processes. Preservation of the neutrality of this forum, fostering collaborative efforts among academia, contract houses, contract research organisations, health regulatory authorities, industry, practitioners, and vendors, is essential to the success of DIA. The Association draws a clear distinction between the dissemination of information and outright commercial promotion of a consultant, commercial product, research institution, or service.
At DIA-sponsored programmes, presentations by persons affiliated with commercial organisations or educational institutions that provide services or products must be limited to scientific, technical or process issues. Presentations should not overtly endorse or recommend a specific product or service. The theme and content of slides, overheads, handouts and other presentation aids should not promote a commercial product or service. This also applies to the use of company logos, which may only appear on the first slide of a slide presentation. In addition, speaker clothing may not carry logos or other company specific emblems. In this way, DIA meetings will be educational, rather than commercial and promotional.
The DIA Office will create and disseminate publicity pertinent to a DIA meeting, workshop, training course, tutorial, or any other DIA-sponsored activity. All such publicity will be distributed directly from the DIA Office. Individuals and organisations can, at their option, make tasteful announcements of their participation in DIA-sponsored meetings, but should refrain from doing so until confirmation of participation has been received from the DIA Office. Any advertising of participation in a DIA-sponsored meeting by an individual or an organisation shall not use any copyrighted material from DIA or the DIA trademark.
The DIA Board of Directors encourages the membership to provide feedback to the DIA Executive Director regarding violations of this policy. The Executive Director will address such violations
In an effort to ensure that you, as the speaker, and DIA are fully compliant with copyright, we ask that you review all of your materials that may need copyright permission. If you already have permission to use these materials, please provide DIA with the source/reference. Copyright permission is a very important issue that DIA takes seriously.