2nd Annual Pharmaceutical Regulatory Affairs Summit

4 – 5 May 2022 | Vienna

Nowadays the pharmaceutical industry is one of the most highly regulated industries in the world. Regulatory affairs (RA) professionals play critical role in this field, that’s why almost everyone who is in this profession wants to know: “What priorities should be on the top of regulatory affairs’ agenda and why is it important for regulators to have further discussions in regulatory forums for being in “harmony” with pandemic consequences?” or “How to avoid inconvenient situations with problems of date expiration and why falsified medicines directive in Europe has led to increased regulatory requirements?” etc. To do this, we have come up with the perfect concept of our event, which will answer all your questions and help improve your skills!

2nd Annual Pharmaceutical Regulatory Affairs Summit was created for highlighting most interactive regulatory topics of 2022, such as: regulatory status in COVID-19’s “hands”, decentralised Clinical Trials, new professional strategies in 2022, statistic of data in regulatory daily basis, hot issues in pharmaceutical regulatory industry and many others. At our pharma conference you’ll learn from leading pharmaceutical companies that will provide interesting materials to all the participants.

This business meeting will give you the understanding about the newest information in pharmaceutical regulatory sphere. The most interesting and hot topics will be discussed here. You will also benefit from great opportunities, such as: communicating with top experts, getting inspiration, insights and establishing important contacts!

Hottest topics that will be discussed this annual

  • Company’s sustainability commitment: What priorities should be on the top of regulatory affairs’ agenda?
  • COVID-19 vaccines and treatments: Why is it important for regulators to have further discussions in regulatory forums for being in “harmony” with pandemic consequences?
  • How to simplify work: Collecting, collating and evaluating scientific data?
  • Regulatory labelling challenges: Communicating proper use and risk of a medicine by both the summary of product characteristics and product license
  • Global public health emergency scenario: Why is it important to expedite regulatory steps?
  • Collaboration with regulatory authorities: How to secure early engagement and dialogue?
  • An overview on growing demand of new professional strategies in 2022
  • How are strong results from regulatory approvals changing therapies for disease, while weaker results may dull hope and shut testing down?
  • Machine learning (ML): Building algorithm to make accurate prediction and act

SUMMIT WILL HOST SPEAKERS FROM THE WORLD’S LEADING COMPANIES

Anirban SADHU

Head. Regulatory Affairs for International Markets

CASE STUDY DAY 2

Regulatory Reliance Pathways

In their quest to ensure early access of patients to medicines, Health Authorities across the world are exploring the possibility of relying on the assessment of other agencies. Lack of appropriate capabilities, management of workload, and efficient utilization of resources are additional reasons for different agencies to rely on each other’s assessments.
This is an area where a lot of development is taking place. The talk will cover an overview of the action in this space.

• WHO
• Emerging markets
• Regulatory Reliance
• Certificate of Pharmaceutical product

Eva WALTER

Vice President, Head Regulatory Affairs CMC

CASE STUDY DAY 1

Nanomedicines and Non-biological Complex Drugs – an Underestimated Regulatory Challenge?

Complex drugs may be either biological, if the active ingredient is derived from a living organism, or non-biological, if obtained by chemical synthesis. In both cases, particle sizes in the nano- or even micro-scale render those drugs different from well-defined small molecules. Characterization, determination of relationships between in vivo performance, quality attributes, and manufacturing process, as well as assessment of equivalence, pose specific challenges, both of scientific and regulatory nature. In contrast to biologicals, however, the regulatory evaluation pathways and approval requirements for synthetic non-biological complex drugs are less well defined and globally not harmonized.

The presentation will focus mainly on the regulatory perspective and shed some light on the following topics:
• What are non-biological complex drugs and why are they special?
• Which regulatory guidance is available?
• Regulatory challenges using the example of iron carbohydrates.

Svetlana MUKHINA

Associate Director Global Regulatory Affairs, Translational Medicine & Devices

CASE STUDY DAY 1

Regulatory Considerations for Companion Diagnostics

• Co-development concept in Precision Medicine
• Regulation of CDx in the US and EU

Domenico VALLE

Regulatory & PRA (Price Reimbursement Access) Director

CASE STUDY DAY 1

The Lessons Learned From The Pandemic

With the Planet hit by the Sars-CoV-2 pandemic since 2020, the need of vaccines and new drugs became an urgent need to meet. On the other hand, the “old” diseases did not go “on vacation”. The regulatory bodies had to fight to combine the need of solutions for the pandemic, as well as the legitimate asks from all the patients waiting for innovative treatments for their own diseases. The development of new drugs as well as the regulatory approval process until the adoption in the clinical practice was profoundly influenced by the pandemic, designing new paths for the third-millennium Regulatory World.

• Sars-CoV2 pandemic
• Unmet clinical needs
• Innovative treatment
• Third-millennium Regulatory World

Peter BERRY

Head of Document Strategy & Excellence

CASE STUDY DAY 2

Attributes of Skilled Regulatory Writers: Comparison to Key Skills of RA Professionals

How similar are the core competencies for these two fields? How do the knowledge, skills, and behaviors required for these two roles differ? Insights will be shared.

• Problem-solving
• Self-management
• Working with people
• Technology use and development

I really enjoyed the programme and different speakers I had opportunity to hear.

– Head Regulatory Affairs Radiology Medical Devices EMEA, Bayer

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

Few photos from our summits

Event programme

Fill your details in the form and we will
send you the whole brochure filled with all details

Your copy of the brochure is prepared.

Inside you will find

  • What keynote speakers will be taking part in the exclusive speaking panel
  • What Case Studies will be discussed by our senior corporate speakers
  • The minute by minute breakdown of the conference