Rules of entry

  1. The closing date for registering nominations is stated at www.regulatoryaffairsawards.org. Entries registered after that date will not be considered. An acknowledgement of receipt will be sent to the contact details on the nomination. TOPRA has no responsibility for entries which are delayed or lost in transit.
  2. All nominations must be made in English.
  3. Incomplete nominations, or those which do not fulfil the criteria, including the time criteria, will not be considered. However, TOPRA reserves the right to contact nominators to request additional information at its discretion.
  4. Material supplied in support of the nominations will not be returned.Hard copy will be archived in confidential storage for 12 months, then destroyed. Electronic versions will be stored in line with TOPRA’s data policy in force at the time.
  5. Scoring frames used in the judging process are confidential to TOPRA but blank frames may be made available on request.
  6. The detailed content of the nomination support material will be treated as confidential but the summary may be used as part of the Awards event or in post-event publicity.It is the responsibility of the person making the nomination to ensure that no material is included that is commercially confidential.
  7. Nominees who are shortlisted will be notified and their name and employing organisation will be used in TOPRA Awards publicity.
  8. Nominees who are not shortlisted will not automatically be contacted.
  9. Shortlisted nominees will be required to attend the Awards ceremony.A representative of the nominee may be substituted by prior arrangement with TOPRA.
  10. The decision reached by the judges will be final and no correspondence will be entered into regarding the final result, which will be announced at the ceremony.
  11. TOPRA reserves the right to vary the length of the shortlist for each category as appropriate.
  12. TOPRA holds the copyright to the Awards logos and supporting material and these may not be used by a third party in any communication including internal company publications, without written permission.
  13. There will be photography and other recordings made of the Awards ceremony which TOPRA reserves the right to use in its publications, social media channels and website.
  14. In the event of no entries being received for an Award that is in the opinion of the judges of suitable standard, no Award will be made.
  15. While it is acceptable in most categories for companies to nominate their own employees, it is generally expected that nominations for the Support category will be client-led.
  16. Should companies wish to nominate their own teams or products, eg, in the Innovation category, the Judges reserve the right to disqualify any entries that are deemed purely promotional – that is, without substantial independent supporting evidence, such as user research or client testimonials
  17. Persons or organisation which are nominated but which do not win may re-enter the same category in subsequent years.However subsequent nominations should contain new /additional information.Re-submission of an identical nomination is not permitted.
  18. Individuals who are winners of their category may not re-enter the same category in future years.They may enter another category but it is expected that the material used to support a subsequent nomination will be substantially different to the first submission.
  19. Companies or teams who are winners of a category may re-enter the same category in future years PROVIDED that the basis of the nomination is different (eg based on a different project or client).
  20. The same nomination material may not be used to enter multiple categories.A company may enter more than one category at a time providing the supporting material for each nomination is different.
  21. However, TOPRA reserves the right to suggest that a submission made for one category might be more suitable for another.Such a recommendation should not be construed as implying favour or a greater chance of success.
  22. In the event of multiple entries being made for single individuals or single companies in a particular category, TOPRA will ask the nominators to consider merging all the material into one nomination.In the event that this is not agreed to by the nominators, the entry that is scored highest by the judges will be deemed to be the representative entry for that nominee in that category.
  23. Nominators must ensure that to the best of their knowledge all information supplied in the nomination form is correct.
  24. Judges are required to declare any conflict of interest and will not be allowed to judge entries in which they have such an interest.
  25. Sponsoring companies may not submit entries for the categories they are sponsoring.The sponsoring of the Awards in any way or at any time will not influence the opinion of the independent judges, which is based purely on the material submitted.
  26. Attendance at the event is by ticket only and anyone without a ticket will be refused admission.

The organisers reserve the right to update these Rules in response to questions which may arise at any time in the Awards cycle.

 

Adhering to transparent processes policy 

The Awards for Regulatory Excellence were established in 2010 to recognise excellence, wherever it may occur in regulatory affairs and highlight the achievements of individuals, teams and organisations in the regulatory affairs community. Over the years, the categories and criteria have developed – and the processes have been refined to ensure independence and fair play during the judging process. This policy has been drawn up to ensure that the processes related to the Awards Programme are transparent.

Who is eligible to enter?

Any individual, team or organisation involved in healthcare regulatory affairs may nominate or be nominated in any category that is appropriate. The only exceptions are:

  • Employees of TOPRA and their relatives;
  • Current members of the TOPRA Board, ie serving on the Board during the Awards year [January to December], although they may nominate or contribute to nominations of eligible candidates;
  • Category sponsors may not make nominations in their category.

Members of the Awards Working Party may be nominated themselves, and nominate or contribute to nominations of eligible candidates.

Judging process

The independent judging panel is drawn from leading figures in the regulatory sector from academics, patients’ representatives, industry leaders to regulators.

The categories are assigned to the judges to ensure that each one is judged from a range of perspectives – and to avoid possible conflicts of interest, eg being given a category which includes a nominee from their organisation.

The judges reserve the right to disqualify any entries that are deemed purely promotional, ie without any substantial independent supporting evidence such as user research or client testimonials.

In the event of multiple entries for single individuals or single companies in a particular category, the entry that is scored highest by the judges will be deemed to be the representative entry for that nominee in that category.

Each judge evaluates the nominations in their category independently and submits their scores on a scoring frame directly to TOPRA Awards Administration. This information is confidential until the winners are announced at the Awards Ceremony.

The judges’ decisions are final and no correspondence will be entered into regarding the final result. Should there be a dead heat in a category, the matter will be referred to the chair of the judges and/or blind referral to another judge on the panel to evaluate the nominations.

Confidentiality

All judges sign a confidentiality agreement regarding the Awards, nominations and scoring systems.

Any information regarding potential categories, nominees, sponsorship and financial information discussed during the organisation of the Awards by the Awards Working Party is strictly confidential.

Any information provided in nominations including support material, with the exception of the summary section is confidential.

The summary information may be used as part of the Award event or post-event publicity. It is the responsibility of the person making the nomination to ensure that no material is included that is commercially confidential.

Conflicts of interest

Judges are not assigned any categories in which any of the entries might be affected by a conflict of interest. Judges are also asked to recuse themselves from judging a category which they have been assigned if they feel there may be a conflict.

The Awards Working Party Working Party (WP) adheres to TOPRA’s conflicts of interest policy. At the outset of meetings, they are obliged to say if there is a potential conflict of interest – and should declare this should an issue arise during the discussion. In such circumstances they would withdraw from the meeting.

The Awards Working Party (WP)

The Awards WP is comprised of TOPRA members who champion individual categories. WP members serve on the committee as individuals not as representatives of their companies. Their role is advisory and they are not involved in policy or financial decision-making. They play no part in the judging process.

TOPRA members are invited to volunteer for the Committee or act as ambassadors for the Awards [email awards@topra.org].

Sponsors and regulatory professionals with business development and commercial roles are not eligible to join the WP due to potential conflicts of interest.

Previous winners are eligible to join the Awards WP.

Sponsorship

The Awards for Regulatory Excellence would not be able to take place without the support from a wide range of sponsors. There are two main types of support available:

  • Category sponsorship – exclusive to a particular category
  • General Championship – non-exclusive.

Sponsors play no role in the judging process, organising the Awards programme or the Ceremony itself. They sign up to the ethos of the Awards without expectation of financial gain to their organisations.

Financial arrangements concerning the Awards are discussed by nominated TOPRA staff and the authorised representatives of sponsors. The content of agreements with sponsors is confidential.

No financial arrangements with sponsors, venues or other third party agreements will be undertaken unless they are with designated TOPRA staff members.

Transparency policy for Awards Programme (January 2017)