2nd Annual Pharmaceutical Regulatory Affairs Summit

26-27 October 2022 | Austria Trend Hotel Ananas

PAST SPEAKERS

SEE THE PREVIOUS SPEAKERS & CASE STUDIES

Tânia BOTELHO DE SÁ VEIGA

Director Regulatory Affairs, EU Lead, Oncology

Monika SZABO

Head of Regulatory Affairs

Luana RICCARDI

Associate Director Regulatory Strategy

Svetlana MUKHINA

Associate Director Global Regulatory Affairs, CDx

Serenella CASCIO

Scientific Affairs Head – Western Europe

CONFERENCE TOPICS 2022

LOOK AT THE TOPICS THAT WERE DISCUSSED

  • 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

Designed for

Members of board, C-level, Senior/Global Vice Presidents, Directors, Heads of departments from the  pharmaceutical industry involved in:

  • Regulatory Affairs
  • Regulatory Intelligence
  • Regulatory Policy
  • Regulatory Compliance
  • Regulatory Operations
  • Regulatory Project Management
  • Regulatory Information Management
  • Regulatory Devices
  • Regulatory Strategy
  • Regulatory Submission
  • Regulatory Sciences
  • Regulatory Documentation
  • Regulatory Labelling
  • Regulatory Development
  • Data Collection
  • Data Management
  • Lifecycle Management
  • Regulatory Writing
CASE STUDY

The Flexibility of Agencies during the Pandemic to Assure Supply Continuity

An unexpected increase in demand for one of our Drug Products because of the COVID-19 forced us to an expedited site transfer. The presentation is about the interactions with different Health Authorities which are making it possible.

  • Authority Interactions
  • Site Transfer
  • Validation

Baerbel GROSSMANN

Associate Director Global Regulatory Affairs CMC Biologics

Svetlana MUKHINA

Associate Director Global Regulatory Affairs, CDx

CASE STUDY

Regulatory Considerations for Companion Diagnostics

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

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

Monika SZABO

Head of Regulatory Affairs

Tânia BOTELHO DE SÁ VEIGA

Director Regulatory Affairs, EU Lead, Oncology

CASE STUDY

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
CASE STUDY

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.

Serenella CASCIO

Scientific Affairs Head - Western Europe

It was a great conference and I was also very impressed with the topics and presentations.

– Executive Director, International Regulatory Affairs, Alexion Pharmaceuticals

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