Acknowledgements

The PIPA Committee would also like to thank the following members of the Training Working Party who contributed to the development of this course:

  • Jacquie Warner, Novartis
  • Manju Bhandari, PIPA TWP
  • Sharon Braithwaite, PIPA Membership & Events Coordinator
  • Anne Turnbull, PIPA Operations Manager

Post Launch

  • Ensure continued, proactive support for Field Force colleagues.
  • Provide regular enquiry statistics reports, if required.
  • Continue active involvement with the cross-functional Product Team.
  • Review and update existing standard responses when required and create new ones when the need is identified.

Day of Launch

Publish SmPC & PIL on live eMC website.

  • This can be prior to launch if marketing authorisation has been received and the product is available through an early access scheme or Individual Funding Request.

One week pre-launch

  • Send out any remaining press announcements e.g. for publications with a 1 week copy lead time, such as Chemist & Druggist and The Pharmaceutical Journal.
  • Confirm that the Medical Information check-list has been completed.
  • Confirm that the completed Materials Questionnaire has been returned to Medical Information.
  • Upload the data to your information repository database, if you have one.

One month pre-launch (or earlier)

  • Submit MIMS & BNF announcements (BNF submission may need to be earlier than this depending on copy deadlines – check with the publishers) – you will need to have an approved price.
  • Draft/approve press announcements and obtain pack shots, if required.
  • Confirm the process for sample or demo pack supply.
  • Ensure Medical Information & Field Force have been fully trained.
  • Source copies of promotional materials and Field Force briefings for reference.
  • Ensure you have the appropriate copyright permissions for any key publications you may be asked to send to Healthcare Professionals in response to unsolicited Medical Information enquiries (e.g. for references cited in promotional materials).
  • Prepare/submit eMC submissions.
  • Confirm when commercial stock will be available.
  • In-Demand submissions.
    • Approved price, confirmed stock availability and a draft or approved SmPC will be required.

Two months pre-launch (or earlier)

  • Ask DataPharm (for eMC) & the Pricing Prescriptions Division (PPD – for Dm&D) to add the generic name to drop down lists.
  • Draft/agree/approve Q&As and standard written responses.
  • Circulate Materials Questionnaire for completion.
  • Draft Medical Information checklist and have regular status reviews.

Six months pre-launch (or earlier)

  • Draft/agree/approve Core Claims.
  • Draft/approve promotional material (MHRA vetting may be required – this may impact timelines).
  • Agree the launch plan and required Medical Information actions with the launch team.
  • Add product to enquiry tracking database.
  • Initiate enquiry statistic reports, if required.
  • Draft a list of key contacts.
  • Confirm copy deadlines for BNF, MIMS, In-Demand.
  • Brief Medical Information colleagues.

In-Demand: It takes 6 to 8 weeks for the information to be passed to the HCP ordering systems so the timing for this will depend on a number of factors including arrival of stock. Discuss with the Product Launch team to determine the most suitable time to upload the information.

External communication

External communications to consider (some of these may fall outside of Medical Information’s remit):

  • Press announcements: Are pack shots required and who will pay if there is a charge for inclusion of a pack shot?
  • The electronic Medicines Compendium – eMC.
  • In-Demand and Dm&D.
  • GP databases (e.g. First Databank).
  • Wholesaler notification and stock availability.
  • Poisons Units and Tic Tac.

Other external communications that may fall under Medical Information’s remit:

  • Patient Support Groups
  • Company website
  • Company product booklets
  • BNF and MIMS
  • Pharmaceutical Journal
  • Chemist & Druggist
  • NICE Awareness Bulletin

Enquiry statistics reports

Your cross-functional colleagues may find enquiry statistics reports useful. If so:

What data do they want to see?

Examples of statistics that may be useful:

  • Number of enquiries.
  • Role of the enquirer (e.g. pharmacist, nurse, doctor).
  • Route of enquiry (email, phone, letter).
  • Did the enquiry come via the Field Force?
  • What was asked?

How often do people want to receive enquiry statistics reports?

  • More frequent reports may be required during the first couple of months post launch.

What format should the reports be in?

  • Excel spreadsheet.
  • Graphs.

Due to data privacy restrictions, all enquiry statistics MUST be anonymised and must NOT contain any details which would allow the reader to identify the enquirer.

Supporting data

Confirm if reprints of key publications are required. If so:

  • Confirm who will order them and from where (e.g.direct from publisher or via your Global colleagues?).
  • Confirm who is going to pay and the number needed.
  • If it is not Medical Information who will be ordering the reprints, request copies for Medical information use.

Abbreviated prescribing information

  • Is it Medical Information’s responsibility to draft and/or approve abbreviated prescribing information?