Overcoming the Regulatory Challenges of Oligonucleotide Therapy CMC

RAC Credits
Virtual ProgramsVirtual Programs
Tuesday, 16 May 2023 (8:00 AM) - Tuesday, 16 May 2023 (12:00 PM) Eastern Time (US & Canada)

With only limited guidance on oligonucleotide therapies, many companies are struggling to develop strategies for chemistry, manufacturing and controls (CMC) that will be acceptable to regulatory agencies. This workshop will introduce best approaches to leverage current guidance on aseptic processing and current GMPs for parenteral drugs to develop a sound approach. Details regarding the completion of specific CMC sections in module 3 of the Common Technical Document (CTD) for drug substance and drug product will also be covered, keeping lifecycle management in mind. Based on the type of oligonucleotide and the manufacturing approach, you will learn the advantages of selecting specific regulatory pathways. 

This workshop will review helpful tips based on approved siRNA and viral vector therapies in the USA and Europe, allowing you to leverage this information effectively. Throughout the workshop, regulatory tools and approaches will be incorporated into the lessons to help guide you on the implementation of risk assessments (ICH Q9), justifications, quality by design (ICH Q8), and product lifecycle management (ICH Q12).


9 February 2023 – 16 April 2023: Early Bird $285 member | $335 nonmember

17 April 2023 – 16 May 2023: Regular $335 member | $395 nonmember

Learning Objectives

At the conclusion of this workshop, participants should:

  • Develop a CMC regulatory strategy for their specific oligonucleotide therapy utilizing the tools, guidance, and examples highlighted.
  • Justify the oligonucleotide CMC section of their application utilizing their established specifications, along with analytical testing, risk assessments, and quality by design (QbD).
  • Manage challenges and changes to their oligonucleotide CMC by utilizing regulatory initiatives for effective planning, early communication, and notification approaches.

Audience Learning Level:

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher-level activities.

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.

Who Should Attend?

Quality assurance, quality control, regulatory CMC, and strategy professionals.


Janmeet Anant

Janmeet Anant

Janmeet Anant, Ph.D., PMP, RAC serves as a Senior Regulatory Consultant at MilliporeSigma, focused on pharmaceutical manufacturing, specifically working on sterile injectables. Janmeet has been a key member of the Paradigm Change in Manufacturing Operations (PCMO), which is a Quality Risk Management (QRM) team of the Parenteral Drug Association (PDA) and a member of the Regulatory Governance Team at BioPhorum. With over 20 years of experience in the pharmaceutical industry, Janmeet has been consulting on complex regulatory strategy projects with pharmaceutical drug manufacturers, leveraging skills from his Project Management Professional (PMP) and Regulatory Affairs Certification (RAC). Janmeet has a Bachelor of Science degree in Chemistry and a Ph.D. in Pharmacology.


RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

All cancellation requests must be submitted in writing to raps@raps.org.  RAPS is unable to accept cancellations by phone.

To transfer a registration, email raps@raps.org with the event title, name of the original registrant, and contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.


For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshop: https://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: at +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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