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Your Tailored Regulatory Affairs Agenda

Suggested agenda for attendees interested in Regulatory Affairs

Wednesday 26 March

Panel Discussion: Making the Pharmacovigilance Legislation Work – A Temperature Check
9:00-10:00 AM 
This session will explore the expriences of implementation of the new pharmacovigilance legislation from the point of view of multiple stakeholders. The new legislation has had impact across a broad range of safety related activities, however this session will focus on areas where we have seen fundamental changes. The session will be conducted as a panel discussion where views from a PRAC member, a Member State Competent Authority, the industry and a patient perspective will be heard. The panel will consider if the objectives of the new legislation are yet being met, in particular with respect to the need to consider risks in the context of benefit, the increased focus on management of risk in the post-marketing environment and the role of Pharmacovigilance Risk Assessment Committee (PRAC). The panel will also discuss their views on the impact of the transparency measures on communication and decision-making.

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Regulatory Harmonisation And Regulatory Convergance – An Update
9:00-10:00 AM
This session brings together speakers who are able to provide experience from different regions and perspectives on regulatory harmonisation and convergence initiatives.

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Creating An Adaptive Pathway For Medicines To Patients – Could This Be An Approach That Fulfills The Needs Of All Decision Makers? A Roundtable Discussion
9:00-10:00 AM
Discuss whether a move away from having the Marketing Authorisation as a ‘magic moment’ by introducing a more staggered, progressive or adaptive approach would create an environment that meets the needs of all stakeholders in the drug development process. Hear perspectives from the HTA, regulatory, industry, agency and patient representatives.

How Do Payers View Current Developments In The HTA And Regulatory Environment?
11:00 AM -12:30 PM
A variety of collaborative efforts have been undertaken in recent years to support the interface between HTA bodies and regulators. How are these interfaces delivering to those that are responsible for paying for drugs and services? Payers will be asked what they do with HTAs and how they include such assessments in their decision-making.

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Hurdles To Overcome To Ensure Regulatory Success For The Next Generation Of Products
11:00 AM-12:30 PM
One of industry’s key responses to the EU’s Horizon 2020 programme is to initiate a series of work streams to investigate new models for R&D. This session will outline the business needs for change within both industry and at the regulator level and will explore what needs to be done to ensure a successful evolution.

Regulatory Town Hall Meeting
2:00-3:30 PM
Put burning questions to expert regulators about transparency, implementation of pharmacovigilance legislation, latest changes to clinical trial legislation, innovation – products in the pipeline and EU-enlargement with Croatia.

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Established Interactions Throughout the Registration Pathway: What Exists and What is Missing?
2:00-3:30 PM
There are multiple opportunities for interactions at different stages during the life cycle of a drug. These are tending to start earlier and should continue through post-marketing data generation. Are these interactions worthwhile and for whom? How can these interactions be improved? Who should be the players? What should be their role?

How to Get Ready for the New Clinical Trials Legislation
4:00-5:30 PM
The new Clinical Trials Regulation is likely to be adopted in 2014 and will become applicable two years thereafter. The new legislation is expected to bring significant improvements with a single submission to the EU database, a single (joint) assessment by all concerned Member States and a single decision by each Member State within competitive timelines. Member States decide how they organise the work between competent authorities and ethics committees. To gain experience, pilots have been conducted by Member States with an coordinated integrated assessment process involving competent authorities and ethics committees through the Voluntary Harmonisation Procedure  as “VHP +”.  As a trade-off for competitive assessment timelines, companies are expected to prepare complete submissions as not to risk the withdrawal of a submission.

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Regulatory Intelligence in Practice – How Regulatory Authorities Inform About Decision Making
4:00-5:30 PM
This session will take a look at some of the hidden treasures found on regulatory agency websites , discuss potential changes regarding provisions of information, and address how stakeholders can get the most out of what is available. Attendees will also consider differences between agencies and regions (EMA, National Agency, HMA initiatives, US, Canada) and use a case study to illustrate different approaches, e.g. with regard to the types of information published on outcome of assessment work.

Thursday 27 March

Biosimilars – Building On European Foundations To Achieve Global Harmonisation

9:00-10:30 AM
Review the fundamental tenets of the biosimilar concept as pioneered by the European regulators and why upholding these is of central importance in view of the fact that these concepts are sometimes misunderstood by stakeholders. The session will review the challenges faced by companies in applying these concepts in a global setting and will conclude with a discussion on stakeholder education followed by a panel discussion.

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The Changing Face of the EMA – Inside and Out: An Overview of the New Structure and Expectations from the Changes
9:00-10:30 AM
In 2013, the EMA embarked on a journey to re-shape the organisation and prepare for the future. The agency’s internal structure has been re- designed to better support the European medicines network and work of the agency's scientific committees, to better share data held by the agency, and to better meet the needs of the agency’s stakeholders. This session will provide an update on the transition to the new structure and practical insight into some of the changes that are underway to its operating processes, including the reinforced product team concept and what it will mean for applicant companies.

Panel Discussion: Regulation 2025 – Stakeholder Vision for the Future of the Global Regulatory Framework Between Now and 2025
11:00-12:30 PM
This session will feature a discussion around the potential future regulatory landscape with a panel of experts, who have a range of perspectives on the topic. Challenging questions will be debated, such as ‘Will we move to a single global Regulatory Agency in the Future?’
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Japanese Regulatory Session/PMDA Update
11:00 AM-12:30 PM
The PMDA will explain its current services and Japanese drug regulation, then answer questions on its future initiatives and challenges for the faster review and better life cycle management of drugs.

Current Status and Future Challenges of Asian Regulatory Environment
2:00-3:30 PM
The Asian region is becoming a pharmaceutical manufacturing hub as well as a key market. This session will clarify current issues and discuss future direction in promoting regulatory harmonisation in Asia, focusing on ICH, APEC and ASEAN.

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Optimising Regulatory Operations Through Use Of Information Technology

2:00-3:30 PM
Receive information on how the regulatory environment can evolve by embracing a new paradigm for worldwide regulatory submissions enabled by information technology. The session will discuss what the business drivers, perceived cost and business benefits, and major barriers and enablers are.

Regulatory Simplification: Vision, Oxymoron, Or ‘Mission Impossible’?
4:00-5:30 PM
Look at how new forms of and initiatives for self-regulation could contribute to a future simplified regulatory framework, urgently required for the efficient conduct of global clinical trials.