Pre-Conference Workshop Day 2023

7:30 am Registration

Workshop A

Tuesday 5th December 2023

8:00 AM to 10:30 PM

Answering Fundamental Regulatory Questions to Manufacture a TRP That Meets Regulatory Expectations

  • Izabela Rejdych Principal Consultant, RegulaNova
  • Anna Kulesza Pharmaceutical Development and Regulatory Affairs Director, RegulaNova Sarl


Regulatory questions are always pressing and meeting expectations is a constant challenge. Getting novel compounds approved and regulators on board, moving through the clinic and more present critical roadblocks. Overcoming this is no easy feat but a very important task.

Join this workshop to:

• Glance over regulatory landscape across major territorial jurisdictions

• Understand regulatory requirements on industrial production of radiopharmaceuticals 

• Gain answers to fundamental regulatory questions

• Overcome common regulatory hurdles

• Understand the regulatory perspective on R&D and routine production

10:30 am Morning Networking Break

Workshop B

Tuesday 5th December 2023

11:00 AM to 1:30 PM

Honing Dosimetry to Increase Adaptability of Therapy


Dosimetry is an indispensable tool for the development of new RPTs from pre-clinical stages until regulatory approval and market introduction. Dosimetry allows us to measure the amount of radiation delivered to tumors and healthy organs. It helps us understand patient-individual therapy response and potential side effects and can allow us to personalize treatment. 

Join this workshop to: 

• Learn how dosimetry can be used to personalize RPT treatment plans.

• Acquire quantitative images to measure the biodistribution of a radiopharmaceutical over time.

• Understand how patient-individual factors affect dosimetry 

• Familiarize yourself with existing tools that simplify dosimetry calculations.

• Enable dosimetry to meet regulatory expectations 

1:30 pm Networking Lunch

Workshop C

Tuesday 5th December 2023

2:30 PM to 5:00 PM

Optimising Combination Therapy to Improve Safety & Efficacy of Your TRP

  • Alejandro Bertolet Assistant Professor of Radiation Oncology, Cardiovasuclar Genetics
  • Germo Gericke Chief Medical Officer, EVP Research & Development, Ariceum Therapeutics
  • Munir Ghesani Systems Chief, Nuclear Medicine, Icahn School of Medicine at Mount Sinai


Combination therapies are the way forward with TRPs. They allow you to administer your drug in a safe manner while maintaining efficacy. While combination therapies are the future, there are still a lot of questions surrounding them and obstacles that must be confronted to make this therapy successful.

Join this workshop to:

• Identify what the logical combination therapy is

• Understand the synergies of other therapies with radiotherapy

• Analyse the sequence in which to administer the combination therapies

• Map out safety priorities when using combination therapies

• Delve into detailed protocols of combination therapies

33446 - Site Tour Resize

5:00 pm End of Pre-Conference Workshop Day