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SMi proudly presents this half-day interactive workshop at the 3rd annual Pre-Filled Syringes East Coast on CMC considerations!

This hands-on workshop provides a didactic discussion on CMC regulatory considerations development of PFS, autoinjectors and related delivery devices. Over the past several years, the regulatory landscape of the combination products has shaped up and culminated into the combination rule 21 CFR Part 4, which has provided unique opportunities for traditional pharma/biopharma and device manufacturers to come together and forge into a regulatory framework that ensures compliance of individual constituents of a combination product. Functional testing of the delivery devices, ergonomics, usability, and human factors are some critical considerations during development and approval of these combination products.

The workshop will discuss the roles and responsibilities of the Office of Combination Products, streamlining 21CFR Part 4 requirements for combination products, functionality testing of PFS/autoinjectors, usability/human factor considerations, and other critical issues. Several case studies will be presented to reinforce the discussion. The participants will leave the workshop with full understanding and appreciation for the CMC challenges and regulatory considerations for the development of PFS/autoinjectors.

Development and approval of combination products continues to be a challenge as drug and device developers need to overcome their silos and mindset and should see a common ground for these products. A recent report published by the Office of Planning at FDA entitled “Combination Product Review: Intercenter Consult Process Study, October 14, 2015” reveals that the review process for the combination products still needs major revamping. Streamlining of the combination rule continues to be a challenge. Many products are facing slowdown and multiple review cycles at FDA and other agencies.

This workshop is aimed at clarifying the confusion and providing a thorough discussion on CMC and regulatory considerations that should be proactively considered for a successful and right-first-time submission and approval of a regulatory application for PFS/autoinjectors and related combination products.

Workshop LEADER


Ravi S. Harapanhalli

Principal, FDAPharma Consulting LLC

Ravi S. Harapanhalli, Ph.D., Principal at FDAPharma Consulting, advises bio/pharmaceutical/device companies on regulatory strategies and Quality-by-Design approaches to medicinal product development and flexible regulatory approaches for drugs, biologics, and drug-device combination products. He also helps companies devise appropriate clinical and regulatory strategies such as 505(b)(2) versus 505(j), biosimilars, and biologics.

Until September of 2015, he was Vice President at PAREXEL International, and served as a Branch Chief in the Office of New Drug Quality Assessment, US FDA. During his tenure of over 7 years at PAREXEL, he worked with numerous clients in developing and getting approvals for their products. He brings his extensive FDA regulatory experience of over 11 years in this consulting strategies. He has wide experience in the CMC/biopharmaceutics review and inspection of a broad range of dosage forms and drug products including radiopharmaceuticals, parenterals, injectable suspensions, solid oral dosage forms, inhalation products, transdermal and topical systems, gels, and combination products including iontophoretic patches, pre-filled syringes and autoinjectors. He has over 25 years of extensive experience in the pharma/biopharma/combination product areas spanning 12 years at US FDA, 8 years in consulting, 11 years in R&D and Biomedical Research and has published over 30 peer-reviewed publications and holds a patent in tumor treatment from Harvard Medical School. He actively presents at national and international meetings on various aspects of medicinal product development.


FDAPharma Consulting LLC

The mission of FDAPharma Consulting LLC is to provide high quality technical and regulatory consultations to aid in medical product development and approval from health authorities.

Workshop programme

13:30 Registration & Coffee

14:00 Workshop Leader's Opening Introduction

Ravi S. Harapanhalli

Ravi S. Harapanhalli, Principal, FDAPharma Consulting LLC
View Bio

14:10 Future Applications for PFS and Autoinjectors in Personalized Medicines

15:10 Regulatory Considerations and Combination Rules

16:00 Afternoon Tea & Networking Break

16:30 Incorporating Human Factors into PFS and Autoinjectors

17:30 Workshop Leader’s Closing Remarks and Close of Workshop


Renaissance Woodbridge Hotel

515 US Highway 1 South
Iselin 08830

Renaissance Woodbridge Hotel

Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.



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CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.


There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.


Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.


Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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SMi Group Ltd, Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
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