VMD Pharmaceutical Industry Customer Satisfaction Survey 2018 MV

VMD Pharmaceutical Industry Customer Satisfaction Survey 2018 MV 005· January 2018· VMD Pharmaceutical Industry Customer Satisfaction Survey

Methodology Timing of fieldwork • Online survey • Q 3 2017 • Customers invited to take part by VMD • 3 weeks Eligibility • Multiple submissions per company were permitted MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey Response rate • Response: 131 vs 218 (previous wave) • Composition of sample similar between waves

Ratings Scale used 1 Poor 2 3 MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey 4 5 Excellent

Analysis “Excellent” • 80%+ of customers rating (4/5 + 5/5) “Good” • 60% -<80% of customers rating (4/5 + 5/5) “Review” • 40% -<60% of customers rating (4/5 + 5/5 ) MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Licensing Administration MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Licensing Administration: Summary 2018: Excellent on all parameters Overall level of service • Approachability • Helpfulness of staff • Knowledge of staff responding to enquiries • Speed of response to enquiries • Usefulness of advice given MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Licensing Administration: Summary: Trend: Maintained excellent performance All parameters maintained and excellent MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Validation performed by the General Assessment Team MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Validation: Summary 2018: Excellent on all but one parameter Overall level of service Approachability of staff • Helpfulness of staff • Knowledge of staff responding to enquiries • Clarity of the points included in validation deferral letter • Speed of response to enquiries • Usefulness of advice • Overall level of service • Ease of identifying the correct person to speak to in this area MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Validation: Summary: Trend: Maintained excellent performance. Improvements in terms of speed of response to enquiries Speed of response to enquiries • Approachability of staff • Helpfulness of staff • Knowledge of staff responding to enquiries • Clarity of the points included in validation deferral letter • Usefulness of advice • Overall level of service MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Joint labelling MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey Caution low base

Joint labelling: Summary 2018: Performance good across all parameters Overall level of satisfaction • Clarity of process • Time scales for the process MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey Caution low base

Joint Labelling: Summary: Trend: Maintained good performance. Possible decrease in overall satisfaction with the service? • Clarity of the process • Timescales for the process MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey • Overall satisfaction with the service? Caution low base

Product Literature Standard (PLS) MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

PLS: Summary 2018: Good across all parameters Overall usefulness • Clarity of guidance in the PLS • The ease of navigation through the guidance • The extent to which the PLS is applied consistently by the VMD during Marketing Authorisation Applications • Pragmatism when applying the PLS MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

PLS: Summary: Trend: Generally maintained good performance with decrease on 1 or possibly 2 parameters The extent to which the PLS is applied consistently by the VMD during Marketing Authorisation Applications • Pragmatism when applying the PLS MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey • Clarity of guidance • Ease of navigation through the guidance?

Pharmaceutical team MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Pharmaceutical team: Summary 2018: Performance mostly excellent Overall level of service Approachability • Helpfulness of the staff • Consistency of approach between • Knowledge of staff responding to enquiries assessors • Speed of response to enquiries • Relevance of questions asked by pharmaceutical quality assessor • Ease of identifying the correct • Relevance of questions asked by pharmaceutical person to speak to in this area safety assessor • Relevance of questions asked by pharmaceutical eco-tox assessor • Pragmatism / willingness to listen to a reasonable alternative view • Usefulness of advice MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Pharmaceutical team: Summary: Trend: Excellent and generally improving? Relevance of questions asked by pharmaceutical quality assessors • Relevance of questions asked by pharmaceutical efficacy assessors • Speed of response to enquiries • Overall level of service? • Pragmatism / willingness to listen to a reasonable alternative view? • Relevance of questions asked by pharmaceutical safety assessors? • Approachability? • Consistency of approach between assessors? Helpfulness of staff Knowledge of staff responding to enquiries Usefulness of advice Ease of identifying the correct person to speak to Relevance of questions asked by pharmaceutical eco-tox assessors MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Biologicals Caution low base! MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey Caution low base

Biologicals: Summary 2018: Performance mostly excellent Overall level of service Approachability • Helpfulness of the staff • Knowledge of staff responding to enquiries • Speed of response to enquiries • Usefulness of advice • Ease of identifying the correct person to speak to in this area • Relevance of questions asked by Biological assessors • Consistency of approach between assessors • Pragmatism / willingness to listen to a reasonable alternative view MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey Caution low base

Biologicals team: Summary: Trend: Many improvements on a mainly excellent performance Usefulness of advice • Pragmatism / willingness to listen to a reasonable alternative view • Consistency of approach between assessors • Approachability? • Overall level of service? • Speed of response to enquiries? • Ease of identifying the correct person? Helpfulness of staff Knowledge of staff responding to enquiries • Relevance of questions asked by Biologicals assessors? Approachability MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey Caution low base

Vaccine Batch Release Caution low base! MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Vaccine Batch Release: Summary 2018: All parameters excellent Overall level of service Quality of issued documentation • Timescales for the process • Advice provided MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Vaccine Batch Release: Summary: Trend: Maintained excellent performance Time scales? Advice provided Quality of issued documentation MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Pharmacovigilance (Phv) MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Pharmacovigilance: Summary 2018: Mainly good, some parameters excellent Overall level of service • Usefulness of advice • Speed of response to enquiries • Knowledge of staff responding to enquiries • Approachability • Helpfulness of staff • Relevance of questions relating to Adverse Event Report • Relevance of questions asked by assessors during applications / renewals • Relevance of questions asked by PSUR assessors • Pragmatism / willingness to listen to a reasonable alternative view • Ease of identifying the correct person to speak to in this area MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Pharmacovigilance: Summary: Trend: Performance mostly good, (some excellent). Several decreases in performance Overall level of service Speed of response to enquiries Relevance of questions relating to Adverse Event reports Pragmatism/willingness to listen to a reasonable alternative view Ease of identifying the correct person to speak to in this area Usefulness of advice MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey Helpfulness of the staff • Relevance of questions asked by assessors during applications/renewals • Relevance of questions asked by PSUR assessors • Consistency of approach between assessors • Knowledge of staff responding to enquiries?

Batch recall MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey Caution low base

Batch recall: Summary 2018: All parameters excellent Overall level of service • The clarity of the VMD’s product and batch recall procedure • The usability of the product and batch recall procedure MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey Caution low base

Batch recall: Summary: Trend: Excellent performance at least maintained if not improved upon • The usability of the product and batch recall procedure The clarity of the VMD’s product and batch recall procedure • Overall level of service MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey Caution low base

GMP or GDP inspections MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

GMP & GDP Inspections: Summary 2018: Excellent across all parameters Overall level of service • Organisation of the inspection • Conduct of the inspection • Clarity of issues identified • Quality of the advice provided by inspectors • Quality of the inspection report • Timescale for the whole process (pre, during and post inspection activities) MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

GMP & GDP Inspections: Summary: Trend: Excellent performance maintained Conduct of the inspection • Organisation of the inspection? • Clarity of issues identified • Quality of the advice provided by inspectors • Quality of the inspection report • Timescale for the whole process (pre, during and post inspection activities) MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Enforcement MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey Caution low base

Enforcement: Summary 2018: “Review” Overall level of satisfaction MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey Caution low base

Enforcement: Summary: Trend: Increasing level of satisfaction? • Overall level of satisfaction? MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey Caution low base

Enforcement: Trend: Overall level of satisfaction improving? % Scoring 4 +5 2018 (n=14) 50% 2016 (n=9) 2014 (n=11) 44% 27% Q 37. Overall, how satisfied are you with the level of service received from the VMD when dealing with illegal veterinary medicines? MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey Caution low base

Enforcement: Positive trend Continues to increase, wave on wave % whose satisfaction had either stayed the same compared with a year ago, or had increased 100% 2018 (n=9) 66% 2016 (n=9) 2014 (n=12) 59% Q 38 Compared to a year ago, has the level of service you have received increased, decreased or stayed the same? MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey Caution low base

Finance MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Finance: Summary 2018: Excellent across all parameters Overall level of service Approachability • Helpfulness of staff • Knowledge of staff responding to enquiries • How easy is it to identify the correct person to speak to in this area • Speed of response to enquiries • Transparency of fee structure for all applications MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Finance: Summary: Trend: Maintained excellent performance Approachability • Knowledge of staff responding to enquiries • Helpfulness of staff • How easy is it to identify the correct person to speak to in this area • Speed of response to enquiries • Transparency of fee structure for all applications • Overall level of service MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Communications MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Communication: Summary 2018: Good to excellent Extent to which charter met VMD makes you aware of relevant information in a timely fashion MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

MAVIS: Summary Readership Section read thoroughly by most customers Performance 2018 Trend: • Half (52%) • Licensing Matters (55%) • Excellent on all parameters • Similar to previous wave • Possible improvements seen in terms of: • Helpfulness of articles • Timeliness on Licensing Matters? MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Website: Summary 2018: Mixed results Accuracy Usefulness Being up to date MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey Ease of finding what you are looking for

Website: Summary: Trend: Similar and mixed Accuracy Usefulness Being up to date Ease of finding what you are looking for MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Europe MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Europe: Summary 2018 VMD & HPRA generally 1 st and 2 nd • • • Quality of advice given Reputation within Europe Consistency of advice Flexibility of approach Issues formal National documentation within a reasonable timescale • Makes you feel like a valued customer • Quality of scientific assessment VMD 6 parameters • Satisfaction as RMS in MRP • Satisfaction as RMS in DCP • Overall value for money 4 parameters MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

And finally. . Overall satisfaction with VMD MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Overall satisfaction 2018 c. f. a year ago: Remains high and similar % Similar level of satisfaction or increased cf. a year ago 2018 (119) 93% 2016 (n=195) 2014 (105) 96% 92% Q 68 Compared with a year ago, would you say that your overall satisfaction with the VMD has. . . Bases on chart exclude DK’s MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey

Next steps. . MV 005· January 2018 · VMD Pharmaceutical Industry Customer Satisfaction Survey