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Ethics and Guidelines Training

BHBIA Spotlight on Compliance - 2022

&MEETINGS Aldgate - 150 Minories, London EC3N 1LS
Thursday 09 June 2022, 9:30 PM - 5:00 PM

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Managing Compliance: Spotlight on Compliance Seminar
This seminar will put the spotlight on what good compliance looks like so that you can make sure that your company meets the highest professional standards. It is aimed specifically at those with an interest in and/or responsibility for compliance within their organisations and will be an energetic and engaging seminar packed with short, sharp presentations, plenty and varied opportunities for interaction and regular breaks.

The focus will be on the practical management of compliance - understanding different perspectives, integrating compliance into BI processes, finding business-friendly solutions and communicating clearly. It’s an opportunity to swap notes, not just with compliance specialists, but with your peers in healthcare BI. The presenters are all members of the BHBIA’s Ethics & Compliance Committee.

The course will assume a good background knowledge of the BHBIA Legal and Ethical Guidelines and the ABPI/BHBIA Guidance for Adverse Event Reporting. 

Programme

9.30   Registration and Coffee

10.00 Welcome and Introduction - Yuliya Fontanetti, Lumanity

Section 1: Making compliance manageable - Kim Smith, BHBIA Ethics & Compliance Advisor, Mo Rice, Medefield and Yuliya Fontanetti

10.15 “Before you abuse, criticize, and accuse, walk a mile in my shoes.” Elvis Presley  

We’ll compare and contrast the differing compliance perspectives of those in a pharma company vs a MR agency vs a fieldwork agency to help you to understand and anticipate their issues and so ease the compliance and research processes, we’ll use a high profile issue to illustrate the benefits of walking in your colleagues shoes.

Including Q&A

11.00 Integrating compliance into BI processes

This session is designed to provide practical guidance to help your organisation avoid becoming over-burdened by compliance, smoothing the integration of compliance and research processes; including:

  • Streamlining MR recruitment
  • Merging data sets
  • Contract negotiations and avoiding hot-spots

Including exercises, discussion time and a coffee break

12.50 Lunch

Section 2: Making compliance real - Rebecca D'Ippolito, Sermo

13.40 Finding business friendly compliance solutions – how to say yes

Case studies – we’ll work through 3 very different case studies to illustrate how to make the ‘rules’ work positively in practice

Compliance clinic – tell us your problems and ask questions

15.10 Tea break

Section 3: Making compliance clear - Catherine Ayland, BHBIA Ethics & Compliance Advisor

15.30 How to communicate compliance

This session will examine how to communicate compliance engagingly, looking at why, what and how to talk about compliance and examining the differences in approach that need to be taken depending on the medium and audience. 

Including exercises and discussion time

16.30 Concluding Discussion - Catherine Ayland / all

16.50 Concluding Comments - Yuliya Fontanetti

17.00 Close

Speakers

Catherine Ayland is an independent market research consultant specialising in the healthcare field.  Catherine has been the BHBIA’s independent Ethics Consultant since 2005 and in this capacity she is responsible for developing and maintaining the BHBIA’s Legal and Ethical Guidelines.  

Prior to working as a freelance consultant, which she has done for the last 23 years, Catherine spent 13 years on the client side, ultimately heading up the international market research team within Boots Pharmaceuticals. 

Catherine's role involves regular liaison with the MRS, the ABPI (Association of the British Pharmaceutical Industry), the PMCPA (the Prescription Medicines Code of Practice Authority), the ICO (information Commissioners Office) and with EphMRA (European Pharmaceutical Market Research Association) and ESOMAR too.

Rebecca has been an active member of the Healthcare Business Insights Industry for 8+ years and has a keen focus on developing quality and compliance standards to foster a productive environment for research innovation. Through key roles in both Agency and Fieldwork businesses, Rebecca’s developed comprehensive expertise in legal, compliance and operational fields. 

As a member of the BHBIA Ethics & Compliance Committee since 2020, she seeks to dynamically champion privacy-first strategies and good industry practice, supporting members to overcome emerging challenges related to the regulatory landscape and ever-progressive developments in technology.

Having worked in the healthcare market research arena for most of her career, Yuliya’s passion for uncovering research insights has been supported by gaining robust experience across numerous therapy areas and methodological approaches over the years. Through her avid interest in high quality data and a real fascination with healthcare research, Yuliya has developed extensive data collection expertise and the desire to deliver ‘gold standard’ within MR by combining the drive for innovative approaches with guideline adherence and understanding.

A naturally keen ambassador for ethical compliance and guidelines, Yuliya joined the BHBIA Ethics & Compliance Committee in early 2018 to help drive compliance across the industry and has since spoken at several successful BHBIA events, eventually taking up a position as a Deputy Chair of the Committee in 2019.

Mo started her career in market research over 30 years ago.  Her focus has been on Healthcare MR since 2002 with the majority of that time spent in data collection across various methodologies.  A member of the BHBIA’s Ethics and Compliance Committee for 7 years. Always keen on compliance Mo joined the Committee and has been instrumental in implementing compliance procedures including GDPR, Privacy, AE reporting and general good practice at the companies she has worked in.  Mo is seen by her peers as a fieldwork expert who ensures compliance.

Kim is a compliance professional with many years’ experience in the pharmaceutical industry. She has held senior company-wide compliance roles at Abbott, Merck and and Leo in the UK over the last 10 years so brings great depth and breadth of expertise to the BHBIA. 

If you notice an accent, that’s because Kim’s compliance roles started 14 years ago at AstraZeneca then Baxter Healthcare in Australia. One of Kim’s great strengths and loves is training, so she’ll be bringing that to the BHBIA table.

Delegate Fees

'Early bird' delegate fees for bookings made on or before 29th April 2022:

  • Members: £404 + VAT / Non-Members: £494 + VAT (These prices include a 10% early booking discount).

Cancellation Policy for early bird bookings: full fee payable / no refunds given; however a substitute delegate can be accepted. (Our standard cancellation policy does not apply).

Delegate Fees for bookings made after 29th April 2022:

  • Members: £449 + VAT / Non-Members: £549 + VAT
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