2nd Annual Pharmaceutical Regulatory Affairs Summit

26-27 October 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

Tânia BOTELHO DE SÁ VEIGA

Director Regulatory Affairs, EU Lead, Oncology

CASE STUDY DAY 1

Challenges of Implementation of the New CTR

The presentation will address some of the practical challenges of the implementation of the new EU Clinical Trial Regulation, not only from the operational side of things (compiling the submission) but also the strategic aspects and wider program/project implications. While there is still not much experience from either the NCAs or the industry, pilot projects enable a first glance at the challenges that may be faced in the near future.

• Overview of EU CTR
• Operational challenges
• Strategic and wider program aspects
• Lessons learned so far

Monika SZABO

Head of Regulatory Affairs

CASE STUDY DAY 2

AIPM National RA Survey about New Trends in RA in a Small Country – Hungary

AIPM (Association of Innovative Pharmaceutical Manufacturers https:// aipm.hu/en) RA WG had a survey about the role of RA country representative in the future: influence of the new trends (e-RA work, outsourcing, and centralization). The presentation shows the result of this survey.

• Goal
• Method
• Result
• Conclusion

Patrick MIDDAG

Associate Director, IT Business Partner Global Regulatory Sciences EU & Canada and IDMP

CASE STUDY DAY 2

Digitalization in Regulatory Affairs Key Trends

In this presentation, we will be covering current key trends and developments in the EU regulatory network which trigger sponsor initiatives in digitalization and a call for action to ensure timely preparedness.

• EMA and EU network digital strategy
• Developments in e CTD4, ePi, and EMA’s IRIS portal
• IDMP/SPOR/DADI
• Cloud-based submissions

Svetlana MUKHINA

Associate Director Global Regulatory Affairs, CDx

CASE STUDY DAY 1

Regulatory Considerations for Companion Diagnostics

• Drug/CDx co-development concept in Precision Medicine
• Regulation of CDx in the US and EU

Serenella CASCIO

Scientific Affairs Head – Western Europe

CASE STUDY DAY 2

What Priorities Should Be on the Top of the Regulatory Agenda to Advance the Sustainability Roadmap

Several measures are taken by pharmaceutical companies more and more to achieve sustainability goals: in addition of recycling pictograms on packs and printed advertising materials, a reduction in the volume of printed advertising materials, adoption of QR code on packs for no drugs, etc. In regards to medicines, there are discussions ongoing at the Trade Association and Health Authorities level to promote the adoption of virtual leaflets. In Europe, medicinal product information is currently available in the form of often quite long paper leaflets found in the medicine folding box. With the increasing digitalization, and in the context of the European pharma law revision, there is a growing desire to make the product information leaflet (PIL) available in a digital format. The presentation aims to stimulate a common reflection on the sustainability roadmap.

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

Sponsors

Few photos from our summits

Event programme

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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