Pre-Conference Workshop Day

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 the one common challenge faced by all drug developers when it comes to TRPs. From understanding the dose of emitters per person, quantities of the dose and how that affects the patient to actually dosing the patient. The need to optimise dosimetry is at an all-time high.

Join this workshop to:

• Overcome the one size fits all assumption

• Improve adaptability of the therapy

• Understand how impurities affect dosimetry

• Enable dosimetry to meet regulatory expectations

• Measure activity of the TRP within the patient to be more patient-specific

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, Massachusetts General Hospital
  • 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

5:00 pm End of Pre-Conference Workshop Day