SPEAKERS

SAMPLE OF KEYNOTE SPEAKERS AND THEIR CASE STUDIES

Baerbel GROSSMANN

Associate Director Global Regulatory Affairs CMC Biologics

CASE STUDY / DAY 1

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
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

Svetlana MUKHINA

Associate Director Global Regulatory Affairs, CDx

SUMMIT WILL HOST SPEAKERS FROM THE WORLD’S LEADING COMPANIES

Tânia BOTELHO DE SÁ VEIGA

Director Regulatory Affairs, EU Lead, Oncology

CASE STUDY DAY 2

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 1

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 1

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.

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
CASE STUDY / DAY 2

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

Tânia BOTELHO DE SÁ VEIGA

Director Regulatory Affairs, EU Lead, Oncology

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.

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

Patrick MIDDAG

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

I really enjoyed learning from highly relevant presentations and lively discussions, and I will be definitely very happy to join the summit next year.

– Associate Director Global Regulatory Affairs, Translational Medicine & Devices, Merck

Event programme

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