Pharmaceutical Regulatory Affairs Summit

5 - 6 May 2021 | Vienna

The pharmaceutical industry is being under continuous pressure and ever-changing now more than ever. For those in regulatory affairs, there are numerous challenges as they plan their regulatory strategy. The current pandemic situation has shown that there is a need for improved collaboration not only with regulatory agencies, but also among pharmaceutical companies. Why do regulatory professionals have such a critical role? How does new European pharmaceutical strategy affect regulatory operations? And how can medical products and devices stay up to date in the age of advancing information technology?

Hottest topics will be discussed this annual

  • Challenges and opportunities of EU pharmaceutical strategy
  • Use of AI in Regulatory Strategy
  • Regulatory agencies – The approval processes
  • Data validation in regulatory submission
  • Directives and regulations on medical devices
  • Regulatory documentations for APIs
  • Regulatory affairs profession: Evolution, responsibilities and career paths
  • Getting medicines to patients faster
  • Models of regulatory collaboration

SUMMIT WILL HOST SPEAKERS FROM THE WORLD’S LEADING COMPANIES

Alex SCHENK

Head ERC Customer and Technology Solutions

CASE STUDY DAY 1

Being Compliant Is No Longer Good Enough

With the accelerating pace of innovation, speed in which regulation is changing and the shift in societal norms, we need to transform ourselves to manage the increasing complexity of organisational risks and return more to society.

• How is Novartis Ethics Risks and Compliance (ERC) organised
• What are the Novartis ERC priorities
• Examples of how Novartis brings ERC to life, code of ethics, integrated risk management, 3rd party risk, management and human rights

Frederic IVANOW

Head of Global Regulatory Intelligence & Policy

CASE STUDY DAY 1

A Regulatory Affairs Perspective on the European Commission Pharmaceutical Strategy for Europe

The overall objective of the European Commission “EU Pharmaceutical Strategy” is to help ensure EU’s supply of safe and affordable medicines to meet patients’ needs and support EU industry to remain world leader and innovator. The strategy will profoundly change the legal, economic and scientific landscape in which we currently operate. This presentation will provide a regulatory affairs perspective on the challenges & opportunities lying ahead of us as the Commission legislative and non-legislative proposals materialise.

• The regulatory affairs elements within the 10 points of action put forward by the Commission
• The industry perspective on the non-legislative and legislative proposals
• The parallel impact assessment and revision of the Orphan Regulation (141/2000) and Paediatrics Regulation (1901/2006)

Figen Kabadas OGE

Head of Regulatory Affairs

CASE STUDY DAY 1

The Role of Regulatory Affairs in Pharma

From being an operational support function to its current role as a strategic partner to the business, Regulatory affairs has gone through a significant evolution over the recent past. This process continues, and the profile of the profession as well as that of the professionals continues to evolve in keeping with the changing paradigms of drug development. This talk will track the course of this evolution and look at what is in store for the future.

• Registration
• Regulatory affairs
• Regulatory science
• Drug development
• Emerging markets

Dr. Anirban SADHU

Director, Regulatory Affairs (Emerging Markets)

CASE STUDY DAY 1

From 'Registration' to 'Regulatory' – The Evolution of the Profession

From being an operational support function to its current role as a strategic partner to the business, Regulatory affairs has gone through a significant evolution over the recent past. This process continues, and the profile of the profession as well as that of the professionals continues to evolve in keeping with the changing paradigms of drug development. This talk will track the course of this evolution and look at what is in store for the future.

• Registration
• Regulatory affairs
• Regulatory science
• Drug development
• Emerging markets

Dr. Anne Silke

HAMMERBACHER

Director, Regulatory Strategy

CASE STUDY DAY 1

Regulatory Affairs iStrategy – RA Strategy in Europe in the Information Technology Age

This presentation will give an overview over EU regulatory landscape, legal framework, and how to accelerate product development in order to get promising medicines to patients faster. There are a few approaches from regulatory agencies, i.e. the PRIME scheme in the centralised approval process at the EMA, but most of the acceleration efforts need to come from companies. An adequate, state of the art regulatory strategy is essential to gain a competitive advantage and get medicines to patients faster.

• The EU regulatory landscape / why regulate medicines?
• Novel ways for drug development and the regulatory strategy behind them – How to get medicines to patients faster?
• Artificial intelligence to aid in product development – The use for regulatory strategy and acceleration
• Early Collaboration with Market Access – How to work hand in hand to overcome access and reimbursement hurdles already during the drug development process
• Regulatory affairs as a driver for competitive advantage and fast-to-market strategies

The topics presented were interesting and I was able to take away some new ideas. I really liked hearing from other pharma companies.

Daiichi Sankyo Europe

We offer to world’s leading companies at our summit

Case Studies

Experience leaders will provide you with lessons learned.

Networking

The chance for market-leading business knowledge networking.

Discussions

All attendees will have a great opportunity to discuss a selection of topics in small groups with their peers.

New Ideas

We are partnering with experienced professionals to provide creative ideas, inspiration, and guidance.

Allan Lloyds Summit mission is to exceed expectations

We are committed to achieving new standards of excellence by providing conference formats that encourages interaction, networking and high class knowledge sharing. With experts, well-supported staff, motivated to deliver quality, Allan Lloyds vision is to be recognized as the global leader in providing high quality business conferences.

What we offer to world’s leading companies

  • Experience-based case studies
  • Round table discussions
  • Impeccable networking opportunities
  • Limited number of seats in the audience ensuring friendly atmosphere
  • No media or press presence

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Event programme

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