SPEAKERS

SAMPLE OF KEYNOTE SPEAKERS AND THEIR CASE STUDIES

Anirban SADHU

Head. Regulatory Affairs for International Markets

CASE STUDY / DAY 1

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
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

Domenico VALLE

Regulatory & PRA (Price Reimbursement Access) Director

SUMMIT WILL HOST SPEAKERS FROM THE WORLD’S LEADING COMPANIES

Anirban SADHU

Head. Regulatory Affairs for International Markets

CASE STUDY DAY 1

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

Svetlana MUKHINA

Associate Director Global Regulatory Affairs, Translational Medicine & Devices

CASE STUDY DAY 2

Regulatory Considerations for Companion Diagnostics

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

Eva WALTER

Vice President, Head Regulatory Affairs CMC

CASE STUDY DAY 2

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.

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 1

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

Svetlana MUKHINA

Associate Director Global Regulatory Affairs, Translational Medicine & Devices

CASE STUDY / DAY 2

Regulatory Considerations for Companion Diagnostics

  • Co-development concept in Precision Medicine
  • Regulation of CDx in the US and EU
CASE STUDY / DAY 2

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-sale 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.

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.

Eva WALTER

Vice President, Head Regulatory Affairs CMC

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 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

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