Medical Writing Special Interest Area Community (SIAC) Medical Communications March Workshop 2012 David Clemow SIAC Chair Melissa Ossanna Communications Coordinator

Special Interest Area Communities within DIA are global communities that are discipline- specific where members can share common experiences and connect with others in their field. –SIACs provide a neutral forum for volunteers to network and exchange information. –SIACs also assist DIA in identifying professional development needs in career and professional development. What is a SIAC? Drug Information Associationwww.diahome.org2

Provide discipline-specific, global community where members share common experiences and knowledge and connect with others in their particular field; provide leadership and networking opportunities. Provide professional, neutral forum for discussion of issues related to the development of medical writing (regulated and non-regulated documents) for the pharmaceutical and biotechnology industries. Our Mission Drug Information Associationwww.diahome.org3

Determine and address educational needs through such activities as designing and conducting shared learning, courses, workshops, and conference meetings. Publicize medical writing field, stimulate SIAC members to engage in the evaluation of writing issues, and encourage dialogue between regulators, academic institutions, and industry. Our Mission Drug Information Associationwww.diahome.org4

SIAC Core Committee Drug Information Associationwww.diahome.org5 Supports activities for over 350 members from around world! Name LastName FirstCompany ClemowDavidEli Lilly and Company EdgrenAlthaMillennium Oncology GawrylewskiHelleJohnson & Johnson Pharmaceuticals R&D MolzonJustinaFood and Drug Administration OssannaMelissaEli Lilly and Company PrestonChristopherF. Hoffmann-La Roche Ltd StewartMaryH. Lundbeck A/S StoltenborgJanetAstraZeneca Clinical Development WilsonSueShire Pharmaceuticals WoodLindaMedWrite, Inc. WoolleyKarenProScribe Medical Communications PindNoelleNovo Nordisk A/S

Opportunities: Individual Leadership Positions and Liaisons Programming Committee Education Committee Membership and Social Committee Publications & Publication Planning Committee ICH E3 Guidance Taskforce Medical Writing Competency Model Project Team India DIA MW SIAC Community Japan DIA MW SIAC Community Professional Growth Drug Information Associationwww.diahome.org6

Activities: DIA Annual Meeting EU Clinical Forum Medical Communication Workshop Programming Drug Information Associationwww.diahome.org7 Programming is Core to SIAC Responsibilities

Activities: Monthly All-SIAC shared learning presentations DIA publications (DIA Forum, Drug Information Journal) Develop new educational outputs (eg, webinars) Education Drug Information Associationwww.diahome.org8

Activities: Social and networking events at meetings Welcome new members Engage members in targeted discussion Membership/Social Drug Information Associationwww.diahome.org9

Activities: Develop publication presence in SIAC to mirror regulatory writing activities Contribute to programming and educational activities Liaison with other publication professional groups Publications Drug Information Associationwww.diahome.org10

Activities: Engage FDA in discussion of clinical study report content Develop ICH guidance update suggestions Work with ICH to develop ICH E3 Q&A ICH E3 Drug Information Associationwww.diahome.org11 example of how SIAC members can engage to make a difference for profession

Activities: Develop professional competency model Communicate about model –Published model in AMWA Journal article –Published article in AMWA Journal regarding application of competency model Medical Writing Competency Drug Information Associationwww.diahome.org12 example of how SIAC members can engage to make a difference for profession

Activities: Regional member committees Regional programming (eg, DIA India Annual Mtg) Education specific to regional needs Regional networking India Drug Information Associationwww.diahome.org13

Japan Drug Information Associationwww.diahome.org14 Activities: Japan Regional Community in development –Regional member committees –Regional programming –Education specific to regional needs –Regional networking

Virtual Community –Facilitating discussion and information exchange in our on-line DIA Connex Community –Communicate with SIAC members –Committee workspace –Resources Shared learning presentations Professional links (over 125 links to information of interest) SME list Committee outputs DIA Connex Drug Information Associationwww.diahome.org15

What questions do you have? Seek out Dave or Melissa anytime? Q&A Drug Information Associationwww.diahome.org16