PIPA Conference 2015 Programme

PIPA Conference 2015 Programme

Delegates who attended conference will be able to view and download the conference presentations from this page. If you did not attend conference, you will not be able to access the presentations. 

Wednesday 14th October

Plenary
Chair: Christine Needham, Novartis

09:00

Registration, Meet & Greet Breakfast

09:55

 Welcome  
 Sarah Hall, PIPA President

10:00

Evaluating the Safety of Medicines
Dr Virginia Acha, ABPI Chief Executive
There is more information than ever available about medicines – before and after they are licensed.  The question is, how can we use this information to drive better understanding of the benefits and risks for the benefit of patients?  And who is responsible for the generation and evaluation?  In this presentation, Ginny Acha outlines the key trends, opportunities and challenges for the evaluation of the safety of medicines.

11:00

Comfort Break

11:30

 Charismatic Impact
 Alex McLaren, The Spontaneity Shop
The guesses we make about other people are often unconsciously based on their physical behaviour. They are making similar guesses about us - so it helps to know what we are doing on a good day so that we can do it more often. This session looks at the high status behaviours we all demonstrate when we are at our most comfortable and lets people into the secret of our best day, so that we can be more charismatic when we need to be

12:30  AGM 2015
13:00

Lunch & Exhibition

TRACK 1: Break Out Sessions

14:00 

 A. Zinc Workshop 2015 – Top Tips, New Functionality Roadmap and ABPI Certification Guidance 
   
Gary Page and Susannah Illingworth, Zinc
Join us for an interactive Zinc MAPS workshop which will provide you with top tips and best practice advice, highlights from the new functionality roadmap, and information on how recent changes to the ABPI certification guidance may affect how you use Zinc. Bring your laptops!

B. Dealing with Difficult Customers
    Alex McLaren, The Spontaneity Shop
This workshop (for a small group of people) takes the insights from the Charismatic Impact session and applies it to the difficult conversations we need to have in professional life, such as handling our colleagues in marketing, negotiating working practice with other companies, and managing our priorities and timelines both internally and externally. Attendees will get personal feedback and practical tips to take away.

C. Pharmacovigilance - The Bigger Picture
   
Shirley-Ann van der Spuy, RedLine Pharmacovigilance
Let us broaden your overall view of pharmacovigilance by providing an international perspective and oversight of the various stakeholders who impact PV. Get an insight into the challenges of pharmacovigilance in developing countries and find out how some creative solutions are being used to promote pharmacovigilance and build a framework to enable compliance that cross global boundaries.

15:30

Tea / coffee & Exhibition

16:00

Break out sessions continued

17:00

 Close

TRACK 2: Managers' Workstream

14:00

 Meaningful Metrics
 Christine Needham, Novartis & Tom Nichols, CRUK
This interactive session will cover the key metrics for ensuring compliant and efficient MI and PV departments, including where the two overlap.

14:45

 Experiences of a Copyright Audit
 
Jacquie Warner, Novartis
Data collection by the Copyright Licencing Authority (CLA): A summary of process and lessons learnt following a CLA audit

15:30

Tea/coffee & Exhibition

16:00

 New Code Requirements Around Recording Transfer of Value to HCPs
 
Heidi Lay, Janssen Cilag
The presentation will give a summary of the new ABPI code requirements around the disclosure of transfers of value. It will outline the background to where the requirements have originated from, the ABPI approach and lastly the Janssen approach to the new code requirement.

16:45

Managers' Hot Topics - Discussion

17:30

Close

19:00 Pre-Dinner Drinks and Dinner

Thursday 15th October

Plenary
Chair: Tom Nichols, CRUK

08:30

Registration

09:00

Yellow Card Road Map
Phil Tregunno, MHRA
The MHRA celebrated the 50th Anniversary of the Yellow Card Scheme in March and has developed a roadmap to consider how it should continue to adapt to the changing technical and cultural environment and to address more actively the issue of under-reporting. The MHRA, have created a strategic roadmap for the Yellow Card Scheme, to ensure it continues to be the primary source of vital drug safety information. This presentation will highlight the key themes from the roadmap, including highlighting the launch of the Yellow Card App

10:00 

The Unique Model of Cancer Research UK's Centre for Drug Development
Julianna Callaghan, CRUK
In May 2014, Cancer Research UK launched its new research strategy with the specific goal to accelerate progress and see 3/4 of patients surviving cancer in the next 20 years.
The CR-UK Centre for Drug Development (CDD) has a key role to undertake in helping the Charity to achieve this aim. As a centre of excellence, CDD’s primary focus is on developing cutting edge therapies that would not progress without our support. The CDD uses its unique infrastructure and capabilities to source, drive and deliver translational programmes, developing new cancer treatments. Fundamental to the CDD is the collaborative approach with which it works in partnership with the Academic, Pharma and Biotech sectors promoting innovation in drug development.
This presentation will detail how the CDD translates today’s science into tomorrow’s medicine in order to bring more treatment options to patients.

10:30

Tea / coffee & Exhibition

Track One: Medical Information

11:00

 The 2015 PMCPA Code of Practice Update in Practice
 
Rina Newton, CompliMed Ltd
Rina will be taking us through some of the proposed amendments to the ABPI Code 2016. In this interactive session, the audience will be considering the likely impact of some of the key changes that will affect people, processes and systems in pharmaceutical companies.

12:00

 Copy Review - an Industry Within the Industry
 
Ralph Carter, PharmaReview
Reviewing and approving materials takes up a disproportionate amount of time.  I will share results from benchmarking exercises on how much time is being spent on this activity, the impact of repeat cycles and explore proposed solutions.   

13:00

Lunch & Exhibition

Track Two: Pharmacovigilance

11:00

Risk Management Plans & Risk Minimisation Material
Dr Kathryn Ord, MHRA
The presentation outlines the requirements for Risk Management Plans and risk minimisation materials, and the various guidances available to help prepare these. General good practice principles are outlined for the preparation and submission (for approval) of additional risk minimisation materials, including consideration of the most appropriate methods of distribution.

12:00

 Going Digital with Risk Minimisation Materials
 
Peter Carroll, Datapharm
Hear about the drivers that are convincing many UK Pharma companies to publish their educational RMMs digitally. Learn from our experience of working with regulators in this developing area. In particular hear specific examples of common barriers and enablers that could help you decide whether to publish your company’s RMMs digitally.

13:00

Lunch & Exhibition

Break Out Sessions

14:00

A. How to Keep Quality and Standards High. A Workshop for Both PV and MI
   Sue Rees, Amgen & Janet Davies, Gilead
Working in PV and MI requires the highest ethical, business and process standards. During this interactive session your workshop leaders will give you practical guidance on how to drive those standards in yourself, your teams and the stakeholders you work with.

B. Changes to inspection findings following the implementation of the 2012 EU pharmacovigilance legislation
Presentation 1, Dr Anya Sookoo


Presentation 2, Dr Sarah Hall    

   Dr Anya Sookoo, Novartis International AG
The session will provide an examination of how EU inspection findings have changed following the implementation of the 2012 EU pharmacovigilance legislation and GVP guidances. The perspective will be that of an experienced ex-regulator, who has now joined the pharma industry and has observed the challenges from both sides.

C. How to Evaluate a Clinical Paper
    Jayne Packham, Jayne Packham Consultancy
This session will explain how to evaluate a clinical paper. It will challenge you to think beyond what is written in the paper.

15:15

Tea/coffee & Exhibition

15:30

 Break Out Sessions Continued

17:00

 Conference Closing Session

17:15

Conference Close