Conference 2021

PIPA Conference 2021 – 29th & 30th September

Although the PIPA 2021 conference was once again a virtual event, we returned to our traditional 2-day format with joint pharmacovigilance and medical information plenary sessions followed by PV & MI presentations and workshops running in parallel. We also delivered a dedicated session on the ABPI / PAGB Codes and a workshop for managers.

Our speakers delivered dynamic, topical presentations and we were delighted by the energy in the virtual rooms.

The full conference programme can be viewed below. For those of you who attended the event, you should be able to see a second copy of the programme for each day with the presentations and recordings of the sessions linked in. If you are unable to see this, then please contact us via pipa@pipaonline.org. PLEASE NOTE: the recordings will only be available until 20th November 2021.

We look forward to welcoming you to PIPA Conference 2022, which will be held at the Hogs Back Hotel and Spa in Farnham on 28th & 29th September 2022. More details to follow soon.

PIPA Conference 2021 Programme

Wednesday 29th September

Plenary

09:00 Welcome – Tom Nichols, PIPA President
09:15 The Art of Brilliance – Dr Andy Cope
This session is absolutely not about challenging you to up your game or work harder, it’s about nudging you to remember who you are at your best. That’s not only good for you. It creates positive ripples that impact on your family, your team and your customers. In a world now dominated by online meetings, THE ART OF BEING BRILLIANT is about unmuting yourself in real life.
The Art of Being Brilliant is based on 20 years of research into positive psychology and the science of human flourishing. The principles are applicable at work and home.
10:15 Comfort Break
10:30 Maternal Health – Current Issues and Possible Solutions –  Dr Dave Lewis, Novartis; Belen Granell Villen, ABPI; Amalia Alexe, Novartis
 This session will cover three aspects of maternal health: Belen will discuss the work being carried out by the ABPI’s Maternal Health Project Group (MHPG), which was set up to address the issue of a deficit of licensed medicines and treatments designed and researched for use in pregnancy and breastfeeding. Dave will talk about the IMI ConcePTION project which aims to generate and disseminate reliable evidence-based information regarding effects of medications used during pregnancy and breastfeeding to women and their healthcare providers. Finally, Amalia will be discussing the research she has undertaken to analyse, from a patient’s perspective, existing pregnancy exposure safety data to assess the availability of current, credible and comprehensive evidence to inform decisions on benefit-risk.
11:30 Comfort Break
11:45 MHRA: Safer Medicines in Pregnancy and Breastfeeding Consortium – Dr Janet Nooney, MHRA
This session will discuss the aims and work being carried out by the Safer Medicines in Pregnancy and Breastfeeding Consortium to improve the consistency of information available to women and their healthcare providers on medicines use during pregnancy and breastfeeding.
12:15  PIPA AGM 2021
13:00 Lunch

Track 1: Break Out Sessions

14:00 A. Workshop: Client Vendor Relationships & SDEA Agreements – Sarah Cox, Cox PharmaConsulting Ltd.
The workshop will cover Safety Data Exchange Agreements (SDEA) and their lifecycle management.  It will also consider the distribution of responsibilities between a marketing authorisation holder and a pharmacovigilance provider and then with those third parties requiring an SDEA.

B. Workshop: ABPI & PAGB Code of Practice – Laura Kelly, PAGB; Dan Sherry & Rashmi Papneja,  RedefineCompliance; Wendy Lloyd-Goodwin, Life Science Law
The session will be looking at the principles underlying the ABPI and PAGB Codes, including best practice advice on copy approvals and recent developments in digital and social media.  Using examples we’ll outline the differences between promoting a POM and OTC product, and the pros and cons when considering reclassification. 

    
15:30 Comfort Break
15:45 Break out sessions continued
17:00  Close

TRACK 2: Managers’ Workstream

14:00 Agile Workshop for Life Science Professionals  – Will Sillar, Insight Partner; Rachelle Furnell, Agile SME; Michael Tedeschi, Agile and Life Science SME; Olivia Morris-Barry, Lead Facilitator
Say goodbye to siloed working, process for process sake, and old-style big bang delivery. In this session we will welcome you to an Agile team, the frameworks and the modern implications of Agile in the life science industry. You will receive a demonstration of how Agile teams work and practical experience of a scrum master. You will walk away with insight on how to move towards an Agile working environment in your team.
17:00  Close

Thursday 30th September

Plenary

09:00 Ageing healthily: a challenge for the 21st century? – Dr James Brown, Director of Aston Research Centre for Healthy Ageing (ARCHA)
10:00 Time to embrace the inevitable reality of human performance in complex systems – Brian Edwards, Chartered Institute of Ergonomics and Human Factors; Helen Hughes, Patient Safety Learning
The professional body for Human Factors and Ergonomics within the UK – the Pharmaceutical Human Factors Special Interest Group (SIG) – was formed in 2015. In this session, we will discuss:

  • The progress made by companies who have placed human performance at the centre of their system design for manufacturing, and how these learnings can be extrapolated to other companies and other parts of the system such as clinical trials and pharmacovigilance.
  • Our collaboration with HSIB and NHS Improvement, to stay aligned to current thinking about systems and human factors, especially from the perspective of the patient.
  • Our communications with ICH who want to know more about the meaning of Just Culture and organisational learning and its application to GCP and quality risk management.
  • The future and our hope to collaborate with PIPA members to develop the sciences based on human factors in pharmacovigilance throughout the life cycle.
11:00  Comfort Break

TRACK 1: Medical Information

11:15 Chatbot and Conversational AI Case Studies – Shailini Blackwell, ConversationHealth & Julie Boothe, Orion Pharma; Justin Mardjuki, Lifelink Systems

Case Study (Conversation Health): From strategic vision to kick off – lessons learned in delivering Orion’s first Med Info conversational AI agent: Orion Pharma has set out to transform the provision of Medical Information services to HCPs and patients – looking to leverage conversational AI as a key channel for digital engagement that meets – and surpasses – the needs of their customers.
In this session, Julie Boothe, Head of Medical for UK/IE will outline the strategic process, decisions and processes that have underpinned Orion’s first conversational AI solution. Alongside Orion’s selected partner, conversationHEALTH, hear how Julie and the team overcame challenges whilst also setting best practices for the global organisation and future conversational AI agent deployments.

Lifelink Systems: Conversational AI is changing the way consumers interact with healthcare providers and life science companies. Lifelink Systems is automating more than 10 million automated, digital interactions with patients and trial participants each year. In this session, we will review several customer case studies to show participants how the technology works, the engagement results, and the ROI our customers are seeing. 
12:20 Global MI – one size doesn’t fit all – Sarah Hall, Mipsol Ltd
This presentation will cover the different structures of Medical Information departments (in-house, outsourced or a mixture of the two) highlighting the pros and cons and things to consider.
13:20 Lunch

TRACK 2: Pharmacovigilance

11:15 Medical Device Regulations– Rob Higgins, Senior Regulatory Affairs Manager, MHRA
In this session, the MHRA will present on the UK device requirements including key considerations manufacturers should be aware of, what inspectors look for during inspections, the common findings seen and any oversights that have been noted. Also, they will highlight how the UK requirements differ from the EU MDR and IVDR.
12:15 MHRA Inspections – what are they looking for? – Raj Bhogal, Jazz Pharma
In this session, Raj will discuss the following:

  • types of inspections
  • what is in scope of PV system inspections
  • what documents could be requested
  • what do the inspectors look for in case processing?
  • recent findings
  • responding to inspections
  • the future of inspections
13:15 Lunch

Break Out Sessions

14:00 A. Workshop: COVID-19 and Pharmacovigilance – lessons learned so far – Tom Nichols, DrivePhase PV
This interactive workshop will discuss:
– how existing treatments have been repurposed and evaluated as treatments for COVID-19
– putting in place a pharmacovigilance system for the vaccineB. Workshop: Pharma and the NHS – the relationship that needs to take the next step? – Harpreet Sandhu, Grunenthal; Alan Ryan, Director of National Programmes for Health Education England; Dave Abbott, Vanessa Chapman & Abigail Scott, UKMi; Gudrun Hubinger & Mariska Lubbe, Pfizer
With guest speakers from the NHS and Pharma, this workshop will explore the extra step the pharmaceutical industry can take to ensure timely provision of essential information – and potentially training – to healthcare professionals to facilitate the best patient experience.    
15:30 Comfort Break
15:45 Break out sessions continued
17:00 Conference Close
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