Conference Programme 2019

PIPA Conference 2019 Programme

Wednesday 2nd October

Plenary

09:00

Registration, Meet & Greet Breakfast

09:55

Welcome    
Ejaz Butt, PIPA President

10:15

Brexit and the Pharmaceutical Industry
Mick Foy - MHRA

This presentation will provide an update on the situation with regard to Brexit and the MHRA’s future role in pharmacovigilance within or outside of the European system. You will also hear information on general topics of interest regarding PV activities in the UK. 

11:15

Comfort Break

11:30

Brexit and the Pharmaceutical Industry - an update 
Steve Hoare, Director of Regulatory Science, Safety and Quality Policy at ABPI

This presentation will provide an update on the latest Brexit situation.

12:30

AGM 2019  

13:00

Lunch & Exhibition

Break Out Sessions

14:00 

 A. Code Compliance Workshop 
     Rina Newton, CompliMed

For those involved with copy approval and healthcare compliance, it is essential that requirements of the Code are well-understood and correctly applied. In this session, not only will we examine recent PMCPA case rulings (e.g. affecting digital activities and communications), we will also (in small groups) consider tricky questions that the CompliMed PIPA Code Forum debate and discuss on a regular basis.

B. Counterfeit Medications
    Dr Dave Lewis and Jean Kilgour-Christie, Novartis Pharma GmbH

Case studies: the impact of counterfeit and falsified medicines on public health.

C. Patient Centricity – how MI teams can provide meaningful information to patients
    Tazneem Anwar and Simran Gill, Janssen

This interactive workshop will look at the new PIPA guidance document on responding to patient enquiries and will explore how MI teams can provide meaningful responses to patients. 

15:30

Tea / coffee & Exhibition

16:00

Break out sessions continued

17:00

 Close

19:00

Pre-Dinner Drinks, Dinner and Evening Networking Event


Thursday 3rd October

Track One: Medical Information

09:00

Findings of UKMi Survey of Pharma MI teams
Fiona Woods & Sarah Cavanagh, UKMi 

In this session, we will present the results of the recent survey of Pharma MI teams by UKMi pharmacists. This interactive session will include the opportunity to discuss what the results mean for the industry, and how they may influence best practice.

11:00

Tea / coffee & Exhibition

11:30

MI Inspection Readiness
Ranjana Khanna, Vifor Pharma

Do inspections make you nervous? Then we can help! This highly interactive workshop will focus on interview readiness, the practical aspects of inspections and the learning opportunities they can offer staff. 

 

13:00

Lunch & Exhibition

Track Two: Pharmacovigilance 

09:00

Data Integrity and Computer System Validation
Trev Simmons, Consultant

Expectations for Computer System Validation and the impact of Data Integrity.

10:00

Eudravigilance and EVDAS
Jose Ortiz, PVpharm

This presentation will provide an understanding of the Eudravigilance system and in particular how the EVDAS is used to support signal detection using EudraVigilance data to Marketing Authorisation Holders of drugs authorised in the EEA.

11:00

Tea / coffee & Exhibition

11:30

Building Your Global PV System in Light of Changing Legislation Worldwide
Shelley Gandhi, NDA Group

13:00

Lunch & Exhibition

TRACK 1: Break Out Sessions

14:00 

A. Medical Information Best Practices
    PIPA MI Workstream

B. Outsourcing and the Joint Client-Vendor PV System
    Tom Nichols, Drive Phase PV

15:00

Tea / coffee & Exhibition

15:15

Break out sessions continued

16:30

 Close

TRACK 2: Managers' Workstream

14:00

Building Subject Matter Experts  
Rebecca Godfrey, Etheo Ltd

In this session we will explore the value of building and empowering Subject Matter Experts (SME) in your teams and organisations.  Using a highly innovative tool, we will explore and discuss our individual insights into distributed control and how this approach can enable our teams to develop robust, efficient and future proofed end-to-end processes with enhanced oversight where issues and risks are identified early, mitigated proactively and lead to robust improvements.  We will also look at ways managers can support their SMEs in developing both the skill and the confidence needed to hold this vital role in the organisation. 

15:00

Tea/coffee & Exhibition

15:15

Building Subject Matter Experts
Rebecca Godfrey, Etheo Ltd

16:30

Close