Biosimilar CMC and Regulatory Challenges - New Course
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Registration Options
Individual Registration
Group Registration
Many pharmaceutical companies, both small and large, are planning or have already entered, into biosimilar manufacturing, but have a limited understanding of the Chemistry, Manufacturing & Control (CMC) comparative studies that are necessary and the challenges they will face bringing their biosimilars into market approval. An increasing number of clinical trials are being carried out for biosimilars and the number of global biosimilar market approvals all suggest a bright future for the biosimilars market in the coming years. But are biosimilars for every company?
Entering into biosimilar development is risky. The competition is stiff. The need to incorporate CMC, Nonclinical and Clinical biosimilarity into the comparability evaluation is time consuming. The regulatory pitfalls are many. Biosimilar development is definitely not as easy, or as inexpensive, as chemical generics. Before jumping into biosimilars, companies should understand the CMC and Regulatory challenges that they will face.
This course will review the regulatory challenges from a CMC perspective of biosimilars. Participants will gain an appreciation of why biosimilars are not treated by the regulatory authorities as bio-generics and will understand the totality of what is required in bringing biosimilars into the marketplace – what has worked and what has not.
Who Should Attend
This course will benefit project managers, qualified persons, directors, managers, supervisors, quality assurance personnel, quality control personnel, manufacturing personnel, regulatory affairs personnel, and any other CMC professional personnel.Time: 8:30 a.m. - 4:00 p.m.
Agenda
Discover What's Happening Each Day
Upon completion of this course, you will be able to:
- Explain the CMC and Regulatory challenges of biosimilar development
- Examine case examples to effectively manage challenges faced with biosimilars
- Apply the underlying core principles of biosimilar development, and the lessons learned, into your company’s biosimilar strategy
Location and Travel
Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Hilton Baltimore
401 West Pratt StreetBaltimore, MD
John Geigert, Ph.D., RAC, President, BioPharmaceutical Quality Solutions
Registration
Pricing Options
More information coming soon.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
Continuing Education for Pharmacists
PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:
PDA #129 | ACPE #0116-0000-15-018-L04-P | 0.6 CEUs
Type of Activity: Knowledge
Continuing Education for Professional Engineers
New Jersey
PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.
The credit value of this course is 6 CPC credits.
North Carolina
PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.
The credit value of this course is 6 PDHs.
Become a Sponsor and/or Exhibitor
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Become a Sponsor
Elevate your brand and maximize your exposure by becoming a sponsor at the Biosimilar CMC and Regulatory Challenges - New Course! Connect with industry leaders, showcase your products and services, and establish your company as a key player in the field.
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Boost your brand and visibility by becoming an exhibitor at the Biosimilar CMC and Regulatory Challenges - New Course! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.
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