About the Awards

The Awards for Regulatory Excellence were established in 2010 to:

  • Reward excellence, wherever it may occur in regulatory affairs
  • Recognise the achievement of individuals, teams and organisations both within TOPRA and in the wider regulatory affairs community.

There are nine categories, covering excellence in every aspect of regulatory affairs, including a Lifetime Achievement Award.

The Awards are judged by a panel of respected figures in the regulatory field and finalists for each category are chosen based on the judges' evaluations.

The winners in each category and the recipient of the Lifetime Achievement Award will be honoured at a glittering dinner and ceremony to be held on 21 November 2019 at Merchant Taylors' Hall in the City of London.

Sponsorships

The Awards programme is an opportunity to associate your brand with outstanding professionalism in regulatory affairs. We offer sponsorship opportunities to suit all types and sizes of organisation.

Rules and Policies

  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 category 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. While it is acceptable in most categories for companies to nominate their own employees, or colleagues to nominate those they work alongside, it is generally expected that nominations for the Support category will be client-led. A consultancy company should not submit a nomination for itself unless the nomination includes significant support material from clients.
  5. Should companies wish to nominate their own teams or products, 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. 
  6. 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. 
  7. Persons or organisations which are nominated but do not win may be re-entered for the same category in subsequent years. However subsequent nominations should contain new/additional information. Re-submission of an identical nomination is not permitted. 
  8. Individuals who are winners of their category may not be re-entered for the same category on the basis of the same material in future years. They may be entered in another category but it is expected that the material used to support this subsequent nomination will be substantially different to the previous submission. 
  9. Individuals may not be entered for more than one category for individual Awards in a single Awards year unless the basis of the nomination and the supporting information are completely different. Specifically, these categories are likely to be Contribution, Horizon, Inspiration and LifeTime Achievement. (PN, this does not apply to individuals who are also being nominated as part of a team in the same year.)
  10. Should more than one nomination for the same individual or group be planned by different nominators, the Awards team will notify the persons concerned to suggest a combined nomination. Unless the nominators jointly decide otherwise the first nomination registered will take precedence.
  11. 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 significantly different as assessed by the TOPRA Awards team. If the material is considered to be insufficiently different the nominator(s) will be advised.
  12. 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 substantially different (eg based on a different project or client). 
  13. 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. 
  14. Material supplied in support of the nominations will not be returned. Hard copy will be archived in confidential storage for up to 24 months after the results are announced, then destroyed confidentially. Electronic versions will be stored in line with TOPRA’s data policy in force at the time and in compliance with the GDPR. 
  15. Nominators must ensure that to the best of their knowledge all information supplied in the nomination form is correct. By submitting the nomination, nominators are making this declaration.
  16. In the event of no entries being received, or if none of those received is of a suitable standard for an Award in the opinion of the judges, no Award will be made. 
  17. 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. 
  18. Judges are required to declare any conflict of interest and will not be allowed to judge entries in which they have such an interest. 
  19. Scoring frames used in the judging process are confidential to TOPRA but blank frames may be made available on request.
  20. TOPRA reserves the right to vary the length of the shortlist for each category as appropriate depending on the quantity and quality of the nominations received that year. 
  21. Finalists will be notified and their name and employing organisation will be used in TOPRA Awards publicity. 
  22. Nominees who are not shortlisted will not automatically be contacted. 
  23. Finalists will be required to attend the Awards ceremony. A representative of the nominee may be substituted by prior arrangement with TOPRA.  
  24. Attendance at the Awards Ceremony and Dinner is by ticket only and anyone without a ticket will be refused admission. 
  25. 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. 
  26. 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. 
  27. 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. 
  28. Should a circumstance arise for which no rule exists, TOPRA reserves the right to refer the matter to Awards WP representatives (or to TOPRA Board members if there is a potential conflict of interest). The Rules will then be updated to reflect the advice received so that any subsequent nominations will be subject to the same decision.

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

 

Transparency Policy

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), may not be nominated as individuals, 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 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.

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 Awards 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 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 TOPRA Board adheres to TOPRA’s conflict of interest policy and at every meeting, Board members must declare any potential conflict of interest on any agenda item for the minutes.  If matters related to the Awards are discussed at the Board meeting (eg their opinion is sought on matters of policy), then those with a conflict will be asked to withdraw from the discussion. 

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

TOPRA members are invited to volunteer for the WP 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, in 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.