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SMi Group's Pre-filled Syringes East Coast 2020

SMi Group's Pre-filled Syringes East Coast 2020 conference takes place in Boston in April

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PLus tHree interactive Post conference WorksHoPs
Wednesday 29tH aPriL 2020, sHeraton boston HoteL, boston, usa
HigHLigHts for 2020:
•	 	Explore	how digital connectivity is being used in the
PFS industry
•	 	Gain insights into control strategies for DDC
developments
•	 	Hear key regulatory updates from the FDA and
industry experts
•	 	Understand	how patient centricity is being
incorporated into device development
•	 	New	for	2020:	Interactive workshop day
cHair for 2020:
Michael	Song,	
Senior Manager, Dosage Form Design and Development,
AstraZeneca
featured 2020 sPeakers incLude:
•	 	Tina	Kiang, Director, Division of Drug Delivery and General
Hospital Devices, and Human Factors, Food	and	Drug	
Administration	
•	 	Alie	Jahangir,	Senior Manager, Combination Products and
Emerging Technologies, Janssen	Pharmaceutical
•	 	Delma	L	Broussard,	Director, Medical Device & Combination
Products PV Expert, CSL	Behring
•	 	Susan	Neadle,	Sr. Director, Global Value Chain Quality Design,
Head, J&J Combination Products CoP, Johnson	&	Johnson
•	 	Diane	Doughty, Senior Scientist, Dosage Form Design &
Development, AstraZeneca
•	 	Jennifer	Hefele	Wald, Director Global Regulatory Affairs Devices
& Combination Products,	Pfi	zer
•	 	Heather	L.	Guerin, Associate Director, Regulatory Affairs - CMC,
Janssen
•	 	Krystin	Meidell, Manager, Regulatory Affairs CMC Medical
Devices and Combination Products, Biogen
•	 	Michael	Friedman,	Combination Product Lead, Amgen	
...	And	Many	More!
www.pfsamericas.com	
Register	online	or	fax	your	registration	to	+44	(0)	870	9090	712	or	call	+44	(0)	870	9090	711
ACADEMIC	&	GROUP	DISCOUNTS	AVAILABLE @sMiPHarM
#smipfsusa
Sheraton Boston Hotel, Boston, USA
SMi Group Proudly Present the 7th annual...
CONFERENCE:
27TH - 28TH
WORKSHOP DAY: 29TH
APRIL
2020Innovations	in	parenteral	device	and	product	development
Pre-Filled Syringes
East Coast
A:	Combination	Product	Development	
–	A	roadmap	for	success			
Workshop Leader: Michael	Song,	Senior Manager,
Dosage Form Design and Development, AstraZeneca	
08.30	-	12.00
B:	Drug	Delivery	Device	Testing	Solutions
Workshop Leader: Michael	Goehring,	Medical &
Pharmaceutical Industry Manager,	ZwickRoell
13.00	-	15.30
C:	How	to	pass	a	Human	Factors	
Validation	study
Workshop Leader: Marc	Egeth,	PhD,	Senior Director,
Core	Human	Factors,	Inc.	and	Pati	Anderson,	Mse,
Senior Associate, Core	Human	Factors,	Inc.
16.00	-	18.20
REGISTER	By	13TH	DECEMBER	AND	SAVE	$400
REGISTER	By	31ST	JANUARy	AND	SAVE	$300
REGISTER	By	28TH	FEBRUARy	AND	SAVE	$200
sPonsored by
08.00	 Registration	&	Coffee
09.00		 Chair’s	Opening	Remarks
	 	Michael	Song,	Senior Manager, Dosage Form Design and
Development, AstraZeneca
digitaL connectivity in tHe Pfs industry
oPening address
09.10		 	Wearable	and	digital	devices	–	a	hybrid	view	between	
pharmaceutical	and	medical	devices
	 •		How	lessons	learned	from	medical	device	can	help	with	
wearable device development
	 •		Electronics,	batteries,	and	IEC	requirements	–	let’s	not	
reinvent the wheel
	 •		Testing	approach	for	novel	/	unique	devices
	Michael	Song,	Senior Manager, Dosage Form Design and
Development, AstraZeneca
9.50	 Digital	health:	The	evolving	regulatory	landscape
	 •		Overview	of	recent	changes	in	regulation	and	guidance
	 •		Case	Study:	Connected	Integrated	Injector
	 •		Case	Study:	Sensor/App	for	Inhaler
	 •		Case	Study:	Dose	Calculator	App
	 	Krystin	Meidell,	Manager, Regulatory Affairs CMC Medical
Devices and Combination Products, Biogen
10.30		 Morning	Coffee	–	Sponsored	by		
11.00	 Simulation	driven	analysis	in	Product	development
	 •		Cloud	based	Numerical	simulation.
	 •		Scripted	simulation	to	achieve	design	optimization
	 	Lin	Li,	Senior Consultant Engineer, Delivery Devices and
Connected Solutions, Eli	Lilly	and	Company
drug Product forMuLation and controL strategies
11.40	 	Challenges	and	opportunities	in	developing	a	system-wide	
stability	program	for	combination	products
	 •		Combination	Products
	 •		Stability	Indicating	Attributes
	 •		Design	Control	process
	 •		End-to-End	Stability
	 •		Drug/Biologics-	Device	Interactions
	 	Alie	Jahangir,	Senior Manager, Combination Products and
Emerging Technologies, Janssen	Pharmaceuticals	
12.20	 	Consideration	for	defi	ning	the	administration	procedure	for	
nano-dose	drug	in	clinical	studies
	 •		Adsorption	phenomenon
	 •		Dose	recovery	considerations
	 •		Mitigation	strategies
	 	Michael	Zhou,	Investigator, Pharmaceutical
Development- Sterile CoE, gsk
13.00	 Networking	Lunch	
14.00	 Technical	overview	of	COP	for	prefi	lled	syringes		
	 •		Key	properties	of	COP
	 •		Case	Study	(New):	
	 	 -	Protein	Adsorption	of	Abatacept	–	COP	vs	Glass
- Immunogenicity test of the aggregates
	 •		Case	Study:		Protein	Adsorption	of	Humira,	Embrel,	
Remicade	–	COP	vs	Glass
	 •		Case	Study:		Protein	Adsorption	with/without	Polysorbate	
(Surfactant)	–	COP	vs	Glass
	 •		Leachable	data	on	COP	syringes
	 	Larry	Atupem,	Sr. Business Development Specialist,
Zeon	Specialty	Materials
14.40	 	Combination	Product	Risk	Management
	 •		Introduction	of	ICH	Q9	and	ISO	14971
	 •		Challenges	of	completing	a	comprehensive	Hazard	
Analysis for combination products
	 •		Design	Risk	Assessments	for	off	the	shelf	components
	 •		Integrating	current	drug	development	risk	assessments	to	
meet	ISO	14971	compliance
	 Tanner	Barnes,	Design Control Engineer II,	Pfi	zer
15.20	 	Qualifi	cation	and	validation	of	VH2O2	industrial	low	
temperature	terminal	sterilizer	process	and	equipment	-	Case	
study	on	process	control	and	monitoring	
	 •		Brief	introduction	to	VH2O2	sterilization	process,	technology	
and applications
	 •		Discuss	validation	and	meeting	ISO14937	standard	
requirements	-	and	looking	at	the	scenario	of	future	VH2O2	
specifi	c	standards
	 •		Present	the	essential	process	variables	forVH2O2	sterilization
	 •		Case	study	on	testing	and	comparing	performance	of	
various hydrogen peroxide concentration measurement
methods	–	and	proposing	an	applicable	approach
	 	Juha	Mattila,	Director,	Sterilization	Technologies,	
STERIS	Corporation
16.00	 Afternoon	Tea	–	Sponsored	by		
REGULATORy	OUTLOOK	–	PART	1
sPotLigHt Presentation
16.30	 	A	regulatory	outlook	and	update	of	the	
combination	product	industry
	 •		Affect	of	TPLC	re-organization	in	CDRH	on	combination	
product	review	(premarket	and	compliance)
	 •		New	guidance	updates
	 	Tina	Kiang,	Director, Division of Drug Delivery and General
Hospital Devices, and Human Factors,	Food	and	Drug	
Administration
17.10	 	EU	MDR	impact	on	premarket	regulatory	requirements	for	
combination	products
	 •		Overview	of	new	requirements	of	EU	MDR	Article	117,	
which	could	result	in	signifi	cant	changes	in	practice,	and	
potential impact to product development timelines
	 •		Collaborations	between	industry	regulatory	networks	and	
EMA	and	Notifi	ed	Bodies	to	clarify	requirements
	 •		Discussion	of	recognized	issues	in	interpreting	Article	117	
requirements	and	potential	paths	forward	to	meet	new	
requirements
	 	Heather	L.	Guerin,	Associate Director, Regulatory Affairs -
CMC,	Janssen
17.50	 Chair’s	Closing	Remarks	and	Close	of	Day	One	
18.30		 End	of	Day	One	Networking	Dinner	-	Invitation	Only	
	Register	online	at www.pfsamericas.com
Pre-Filled	Syringes	East	Coast	Conference
DAy	ONE		|		MONDAy	27TH	APRIL	2020		 	 	 										 	 www.pfsamericas.com
08.30	 Registration & Coffee
09.00 	 Chair’s Opening Remarks
	 Michael Song, Senior Manager, Dosage Form Design and
Development, AstraZeneca
Lifecycle Management for Combination Products
	OPENING ADDRESS
09.10	 Combination products integrated development
	 •	Combination Products Regulations are evolving globally  
	 •	One consistent undercurrent to this dynamic regulatory
environment is the drive for successful practices and control
strategies throughout the combination product lifecycle, to
assure public health, ensuring risk is commensurate with product
complexity and patient needs
	 •	In this presentation we’ll review combination products integrated
development and risk management considerations and
essential performance requirements to support robust product
development and lifecycle management
	 Susan Neadle, Sr. Director, Global Value Chain Quality
Design, Head, JJ Combination Products CoP,
Johnson  Johnson
09.50	 Combination product lifecycle management
	 •	Why is it important to incorporate risk management and
design controls into the LCM of Combination products?
	 •	How to manage change through design controls
	 •	Use of platforms for optimization of development time
and costs
	 •	Regulatory standards to consider
	 Michael Friedman, Combination Product Lead, Amgen
10.30 	 Morning Coffee – Sponsored by  
11.00	 Lifecycle management of combination products
- a regulatory perspective
	 •	Regulatory’s role in the product change assessments and
DHF deliverables
	 •	Handling legacy combination products
	 •	What should be submitted for legacy and new
combination products?
	 Jennifer Hefele Wald, Director Global Regulatory Affairs
Devices  Combination Products, Pfizer
Regulatory Outlook – Part 2
11.40	 Regulatory Perspective on Human Factors Requirements for
Combination Products
	 •	Overview of human factors topics including platform
approaches, training programs, and Instructions for use
	 •	Importance of risk analysis and risk considerations
in development of human factors studies and
communication of results
	 •	Best practices for incorporating human factors studies
results into regulatory filings
	 Heather L. Guerin, Associate Director, Regulatory Affairs -
CMC, Janssen
12.20	 FDA postmarketing safety reporting for combination
products guidance
	 •	Reporting requirements for combination products
under PMSR final rule
	 •	Overview of report types based on constituent parts
	 •	Hypothetical examples of report types
	 Delma L Broussard, Director, Medical Device  Combination
Products PV Expert, CSL Behring
13.00	 Networking Lunch  
	
Device Development
	 PANEL DISCUSSION
14.00	 Combination products evolving trends
	 •	What are some of the significant challenges that
people face in implementation of combination product
regulations?
	 •	Is there anything uniquely challenging from a drug-led
manufacturer versus a device-led manufacturer?
	 •	Can you comment on Post-Marketing Safety Reporting for
Combination Products as it relates to risk management?
	 Panel Moderator: Susan Neadle, Sr. Director, Global Value
Chain Quality Design, Head, JJ Combination Products CoP,
Johnson  Johnson
	 Panelists: Jennifer Hefele Wald, Director Global Regulatory
Affairs Devices  Combination Products, Pfizer
	 Delma L Broussard, Director, Medical Device  Combination
Products PV Expert, CSL Behring
	 Alie Jahangir, Senior Manager, Combination Products and
Emerging Technologies, Janssen Pharmaceuticals
	 Leonel Vanegas, President/Principal, Resmedica
14.40	 Latest date of oxycapt multilayer plastic vial  syringe
	 •	Comparison among OXYCAPT, COP and Glass
	 •	Excellent Oxygen  Ultraviolet Barrier
	 •	Oxidation and Aggregation Studies of Antibody
	 •	Development of Staked Needle Syringe
	 Shota Arakawa, Researcher, Mitsubishi Gas
Chemical Company, Inc.
15.20	 Afternoon Tea – Sponsored by  
15.50	 Design considerations for optimizing the user experience
of prefilled syringes and injection devices
	 •	Device features of prefilled syringes and injection devices
to support candidate device selection
	 •	Design considerations for minimizing pain upon injection
	 •	Case study of exploratory clinical study to evaluate
injection parameters
	 Diane Doughty, Senior Scientist, Dosage Form Design 
Development, AstraZeneca
16.30	 How quality can help drug-device combination teams
become agile in a changing regulatory landscape
	 •	The role of quality and CMC during drug-device
combination products evolution
	 •	Five steps towards becoming agile and flexible
anticipating formulation changes before NDA/BLA filings
	 •	From pre-filled into a different presentation format after
marketing approvals
	 •	Life-Cycle Management considerations (e.g. data you’ll
need to demonstrate to the regulatory agencies)
	 Leonel Vanegas, President/Principal, Resmedica
17.10	 Chair’s Closing Remarks and Close of Day Two
Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Pre-Filled Syringes East Coast Conference
Day TWO  |  TUESday 28th APRIL 2020 	 	 	   	 	 www.pfsamericas.com 	
Hear from pharma and regulatory KOLs
leading the way in Pre-Filled Syringes
Engage in case studies, regulatory outlooks
and panel discussions exploring the industry
We keep networking at the forefront when it
comes to our attendees. Expand your
community, benefit from the right people and
secure future collaborations
Overview	of	the	workshop:
As more and more drug products are being developed
as combination products, device development plays
a critical role. To successfully develop a combination
product,	it	requires	collaboration	and	consideration	from	
multiple angels.
In this workshop we will dive into each of these factors
from primary container and device selection to how to
manufacturing considerations and ways to platform and
streamline development activities without running into
regulatory risks. Some of the areas we will explore include
•		Drug	product	and	primary	container	interaction	and	
impact on device selection and development
•		How	to	select	the	right	device	and	utilizing	design	
control	and	strategic	approaches	to	minimize	
development risks and timeline.
•		Design	verifi	cation,	biocompatibility,	extractable	and	
leachables
•		Packaging	and	manufacturing	consideration
•		Stability	and	controls	strategy
Reasons	to	Attend:
•		Learn	about	interlinked	relationship	between	drug	
product, primary container, device, and packaging.
•		Consideration	and	ways	to	minimize	device	
development risks
•		Dive	into	design	verifi	cation,	biocompatibility,	EL,	and	
control strategies
•		Role	packaging	play	in	successful	combination	
product
•		Process	development	and	consideration
About	the	workshop	Leader:
Michael	 Song	 leads the Device Functionality, Safety
and Digital Connectivity group at MedImmune, a
Member of the AstraZeneca Group. In his current role,
he oversees device functionality; primary container
science and technology; biocompatibility; container
closure integrity testing; and digital connectivity. Prior
to his current role, Michael was head of Device and
Package Engineering at Adello Biologics, a member
of Amneal Pharmaceutical. He also has held key
engineering lead and toxicology SME positions at
Stryker, Kavlico, and other companies. Michael holds a
BS in Electrical Engineering from Purdue University and
PhD in Neuroscience and Toxicology from Iowa State
University.
Combination	Product	Development	–	A	roadmap	for	success
Post conference WorksHoP a
08.30	-	12.00
	Register	online	at www.pfsamericas.com
Post	Conference	Workshop	Day
Wednesday	29th	April	2020,	Sheraton	Boston	Hotel,	Boston,	USA														www.pfsamericas.com
Workshop Leader:
Michael	Song,	Senior Manager, Dosage Form Design
and Development, AstraZeneca
Post conference WorksHoP b
13.00	-	15.30
Drug	Delivery	Device	Testing	Solutions
Overview	of	the	workshop:
In the drug delivery device, testing world, the regulatory
requirements	 add	 complexity	 to	 the	 simplest	 of	 test.	
What occurs when the testing moves from the simple
to multifaceted is an exponential amount of effort to
meet industry demands. Finding the best partner starts
with a full understanding of your internal and external
requirements.	Uncovering	the	unknowns	is	an	arduous	
task but a crucial one to your success.
About	the	workshop	leader:
Michael	Goehring,	Medical  Pharmaceutical
Industry Manager, ZwickRoell
BSEE	 –	 Instrumentation	 and	 Systems	 –	 University	 of	
Connecticut Field Systems Engineer for materials
and component test systems Territory Manager
for Laboratory Information Management Systems
District and Regional Sales Manager for materials and
component test system North America Sales Manager
for material preparation and analysis Industry Manager
–	Medical		Pharmaceutical.
ZwickRoell has years of experience in delivering
innovative solutions for drug delivery systems that
reduce	operator	infl	uence,	which	increases	accuracy,	
repeatability, reproducibility and traceability of test
results.
Post conference WorksHoP c
16.00	-	18.20
How	to	pass	a	Human	Factors	Validation	study
Overview	of	the	workshop:
Hear expert opinions on how to structure a human
factors	 program	 from	 product	 conceptualization	 and	
early design through risk analysis development and
iterative usability testing in order to pass a human factors
validation	study	on	the	fi	rst	attempt.
Reasons	to	Attend:
•		Learn	how	to	build	and	optimize	your	company’s	
human factors and usability engineering process
and how that can be applied to every development
project	in	order	to	reduce	development	delays	and	
improve	the	chances	of	fi	rst-time	success
•		Discuss	the	regulatory	imperative	of	HFE,	and	the	focus	
on use-related harm, as well as other uses of HFE
•		Discuss	how	HFE	as	an	RD	activity,	not	a	
documentation activity
•		Discuss	development	and	testing	of	instructions	
for	use	(IFU)	
•		Discuss	how	to	scale	HFE	programs	and	how	programs	
vary from product to product
About	the	workshop	leaders:
Pati	andMarc	manage	all	aspects	of	human	factors	projects	
at Core Human Factors. Our experience includes hundreds
of different types of medical devices and combination
products. We have worked on every phase of HF work, run
studies	all	around	the	world,	and	helped	dozens	of	different	
companies manage their HF programs and navigate
regulatory pathways. Part of our work includes IFU design,
development and testing.
Core	 Human	 Factors,	 Inc.	 (Core) is a consulting group
based outside of Philadelphia, PA, staffed by human
factors specialists with a wide variety of backgrounds. We
specialize	in	human	factors	testing	for	medical	devices	and	
health care systems. Core has helped hundreds of products
successfully navigate FDA review and gain CE marks, and
our	 researchers	 have	 published	 dozens	 of	 publications	 in	
peer-reviewed	journals.	In	addition	to	user	testing,	we	also	
assist in the design of products, instructional materials, and
training programs; risk analyses; user needs documentation;
and ideation sessions to facilitate invention and human-
centered design in health care and medicine.
Programme
16.00	 Scaling	HFE	-	Doing	More	with	Less	
	 •	 	Regulatory	imperative	and	focus	on	safety
	 •	 	Time	and	cost	tradeoffs	in	iterative	design
	 •	 	Can	you	be	a	biosimilar	or	generic?
	 •	 	Making	changes	after	a	Validation
16.35		 Human	Factors	Protocols	that	Work
	 •	 	Valid	assessments	of	risks
	 •	 	Non-biasing	study	designs	and	interview	techniques
	 •	 	Pivoting	from	a	pilot
	 •	 	Pre-submission	process
17.10		 Instructions	for	Use,	a	Human	Factors	Perspective
	 •	 	Why	IFUs	should	be	considered	early	and	often	
	 •	 	Initial	design
	 •	 	Iterative	development
	 •	 	The	good,	the	bad,	and	the	ugly
17.45		 Case	Studies		
	 •	 	Case	study	#1	
	 •	 	Case	study	#2
	 •	 	Case	study	#3
	 •	 	Case	study	#4
Programme
13.00	 Drug	Delivery	Device	Testing	Overview
	 •	 	Importance	of	a	URS	(User	Requirements	Specifi	cation
	 •	 	Functional	Design	Specifi	cation
13.35	 (Prefi	lled)	Syringe	testing	and	spring	simulation	(power	pack)
	 •	 	Glide	Force	New	ISO	7886-1
	 •	 	ISO	11040-4,	-6,	-8
	 •	 	ISO	80369-7,	-20
14.10		 Auto	injector	and	pen	injector	testing	–	wearable	device	testing
	 •	 	ISO	11608-1	(Pen),	ISO	11608-2	(Needle),	ISO	11608-3	
(Cartridge)
	 •	 	ISO	11608-2	(Needle)
	 •	 	ISO	11608-3	(Cartridge)
	 •	 	ISO	11608-5	(Full	Function	test	on	Auto	Injectors)
	 •	 	ISO	11608-6	(Wearables)
14.45	 Device	testing	–	regulatory	demands
	 •	 	21	CFR	Part	11	–	Traceability	(When,	Who,	What,	Why	
and	Who	is	Responsible)
	 •	 	DQ,	IQ,	OQ	and	why	not	PQ.		MDR	Europe
15.20	 Session	Recap	
15.30		 Afternoon	Tea	
Workshop Leader:
Michael	Goehring,	Medical Pharmaceutical
Industry Manager, ZwickRoell
Workshop Leaders:
Marc	Egeth,	PhD,	Senior Director,
Core	Human	Factors,	Inc.
Pati	Anderson,	
Mse, Senior Associate,
Core	Human	Factors,	Inc.
Programme
08.30	 Registration	and	Coffee
09.00		 	Session	1
	 •	 	Primary	Containers	Components
	 •	 	Drug	Product	and	Primary	Container	interaction	and	
considerations
	 •	 	Extractable	and	Leachables	
09.35	 Session	2
	 •	 	Device	selection	and	characterization	
	 •	 	Considerations	from	process,	manufacturing,	packaging,	
and usability standpoint
	 •	 	Key	drivers	for	success	and	novel	devices		
10.10		 Morning	Coffee
10.30	 Session	3
	 •	 	Process	and	manufacturing	overview	considerations	
(clinical,	commercial,	and	automation)
	 •	 	Packaging	considerations	and	risk	reduction
	 •	 	Risk	Assessment,	Controls	strategy	and	DV	testing
11.05	 Session	4
	 •	 	Design	Verifi	cation	and	Validation
	 •	 	Stability	approaches	
	 •	 	Future	trends,	digital	health,	wearables,	and	novel	technology	
11.45	 Session	Recap	
12.00		 Networking	Lunch
ProudLy sPonsored by:
sPonsorsHiP and exHibition oPPortunities
SMi	offer	sponsorship,	exhibition,	advertising	and	branding	packages,	uniquely	tailored	to	compliment	you	company’s	marketing	strategy.	
Prime	networking	opportunities	exist	to	entertain,	enhance	and	expand	your	client	base	within	the	context	of	an	independent	discussion	specifi	c	
to	your	industry.	Should	you	wish	to	join	the	increasing	number	of	companies	benefi	ting	from	sponsoring	our	conference	please	call:	
Alia	Malick,	Director,	on	+44	(0)	20	7827	6168	or	email:	amalick@smi-online.co.uk
Marketing oPPortunities
Want	to	know	how	you	can	get	involved?	Interested	in	promoting	your	services	to	this	market?		
Contact	Jinna	Sidhu,	Marketing	Manager,	+44	(0)	20	7827	6088	or	email:	HSidhu@smi-online.co.uk
Pre-Filled	Syringes	East	Coast	Conference
www.pfsamericas.com
	Register	online	at www.pfsamericas.com
Aptar	Pharma is a leading provider of innovative drug delivery systems to pharmaceutical, consumer healthcare and biotech customers worldwide, enabling
safe, convenient and compliant medication delivery. Trusted partner of the pharmaceutical community, we provide our customers with a large range of
specialized	drug	delivery	devices,	components	and	analytical	services	backed	by	decades	of	proven	expertise.	We	have	broad	therapeutic	expertise	in	
Nasal,	Pulmonary,	Injectables,	Eye	Care	and	Dermal	delivery	routes,	among	others.	Our	global	manufacturing	footprint	of	sites	in	Argentina,	China,	France,	
Germany,	India,	Switzerland	and	the	U.S.	provides	security	of	supply	and	local	support	to	our	customers.	 www.aptar.com/pharma
Credence	 MedSystems	 is	 an	 innovator	 in	 injectable	 drug	 delivery	 devices.	 Credence’s	 philosophy	 of	 Innovation	 Without	 Change	 results	 in	 products	
that	impress	and	protect	end-users	while	preserving	pharma’s	existing	processes,	sourcing	strategies	and	preferred	primary	package	components.	The	
Companion® family of syringe systems includes proprietary needle-retraction technology, reuse prevention and other critical safety and usability features in
Staked	and	Luer	needle	formats.	The	Dual	Chamber	platform	offers	single-step	mixing	and	injection	for	drugs	requiring	reconstitution	at	the	time	of	delivery.	
Additional	products	such	as	metered	dose	devices,	multi-length	staked	needles	and	other	novel	devices	address	the	needs	of	specifi	c	therapeutic	markets.	
www.credencemed.com
Mitsubishi	Gas	Chemical	is	a	leading	company	in	the	fi	eld	of	oxygen	barrier	and	absorbing	technologies.	Based	on	these	technologies	and	experiences,	we	
have successfully developed multilayer plastic vial and syringe having excellent oxygen, ultra violet and water vapor barrier. The products make it possible to
replace	glass	with	plastic	for	injectable	drugs.	 www.mgc.co.jp/eng/products/abd/oxycapt.html
Polyplastics	is	the	leading	maker	of	TOPAS	COC	(cyclic	olefi	n	copolymer),	a	glass-clear,	incredibly	pure,	break-resistant	plastic	for	drug	delivery,	including	
syringes, vials and cartridges. The benign COC medical polymer presents a nonreactive surface for advanced molecules. Additionally, TOPAS COC offers
high moisture and chemical resistance, barrier and UV transmission. https://topas.com
STERIS	Life	Sciences	is	your	trusted	partner	in	contamination	control.	For	over	100	years,	STERIS	has	been	a	global	leader	and	expert	in	the	industries	of	
sterilization,	cleaning	and	infection	control.	Today,	we	continue	to	build	on	this	heritage	by	providing	the	products	and	resources	you	need	throughout	every	
step	of	your	process.	From	innovation	to	results,	our	comprehensive	portfolio	of	products	and	services	is	designed	to	meet	your	needs.	With	offi	ces	located	
worldwide	and	technicians	in	over	100	countries,	you	can	count	on	us	to	be	where	you	are	when	you	need	us,	every	step	of	the	way.	Trust	STERIS	Life	Sciences	
to help you create a healthier and safer world. 	www.sterislifesciences.com
The	Weiss-Aug	Group is your global partner for the design support, development, engineering and manufacture of medical devices and drug delivery
components	and	sub-assemblies.	With	specialized	knowledge	and	state-of-the-art	equipment,	The	Weiss-Aug	group	delivers	the	latest	technologies	for	
Disposable Safety Products, Drug-Delivery Products, Orthodontics, Ophthalmic Disposables and Devices, Electrosurgery.	 www.weiss-aug.com/
ZEON’s	Zeonex®	and	Zeonor®	cyclo	olefi	n	polymer	(COP)	allow	for	advanced,	break-resistant	syringes,	vials	and	lyophilization	containers	for	protein-based	
biopharmaceuticals,	high	viscosity	drugs,	and	contrast	media.	They	also	offer	high	purity,	“glass-like”	transparency,	sterilization,	low	water	absorption,	and	
superior moldability, as well as overcome protein adsorption and ph shift concerns. www.zeonex.com
ZwickRoell	manufactures	and	supports	a	wide	range	of	materials	testing	machines,	systems	and	accessories	for	use	in	research,	quality	control,	production	
environments and academia. Our extensive portfolio of testing machines and accessories cover almost every segment, from medical and pharmaceutical
packaging to surgical instruments and orthopaedics and biomaterials. www.zwickroell.com
Pre-Filled Syringes East Coast
Past	Attendee	Breakdown
110+
Industry professionals
from Europe and beyond
7+
Dedicated hours
of networking
Business
Development
Manager 22%
Senior
Engineer
21%
Director 17%
Project	
Manager
15%
Senior Device
Manager 12%
Senior Principal
Scientist 13%
Breakdown	of	attendee	-	Job	function
suPPorted byofficiaL
Media Partner
key Media Partners
Attendee	Geography:
USA
78%
Europe
12%
United
Kingdom 4%
Asia
Pacifi	c 2%
Africa	1%
Canada
3%
Pre-Filled
Syringes Series
save tHe date
Conference:
October 2020
Sheraton Boston Hotel,
Boston, USA
Wearable	Injectors	and	
Connected Devices
USA
Conference:
15th	-	16th	June	2020
Hyatt Regency Mission Bay,
San Diego, CA, USA
Pre Filled Syringes
West Coast
Conferences:
14th-15th	September	2020
San Francisco, USA
Pre Filled Syringes
San Francisco
neW
for
2020
neW
for
2020
PRE-FILLED	SyRINGES	EAST	COAST	2020
Conference:	Monday 27th  Tuesday 28th April 2020, Sheraton Boston Hotel, Boston, USA
Workshops: Wednesday 29th April 2020, Sheraton Boston Hotel, Boston, USA
4	WAyS	TO	REGISTER
www.pfsamericas.com		
fax your	booking	form	to	+44	(0)	870	9090	712
PHone	on	+44	(0)	870	9090	711
Post your booking form to: Events Team, SMi Group Ltd,
India	House,	45	Curlew	Street,		London,	SE1	2ND,	UK
If	you	have	any	further	queries	please	call	the	Events	Team	on	tel	+44	(0)	870	9090	711	or	you	can	email	them	at	events@smi-online.co.uk
Unique	Reference	Number		
Our	Reference	 	 P-315
docuMentation
I	cannot	attend	but	would	like	to	Purchase	access	to	the	following	Document	Portal/
Paper	Copy	documentation.	 	Price		 	 Total
□ Access to the conference documentation
on the Document Portal £499.00		 +	VAT		 £598.80
□ The	Conference	Presentations	–	paper	copy £499.00		 -		 £499.00
(or	only	£300	if	ordered	with	the	Document	Portal)
Payment must be made to	SMi	Group	Ltd,	and received before the event, by one of
the following methods	quoting	reference	P-315	and	the	delegate’s	name.	Bookings	
made	within	7	days	of	the	event	require	payment	on	booking,	methods	of	payment:
□ uk bacs Sort Code 300009,	Account 11775391
□ Wire	Transfer	 Lloyds	TSB	Bank	plc,	39	Threadneedle	Street,	London,	EC2R	8AU
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VAT at 20% is charged on Document portal and literature distribution for all UK customers
and for those EU customers not supplying a registration number for their own country here.
□ Book	by	by	13th	December	to	receive	$400	off	the	conference	price
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earLy bird
discount
Payment: If payment is not made at the time of booking, then an invoice will be issued and must
be paid immediately and prior to the start of the event. If payment has not been received then
credit	card	details	will	be	requested	and	payment	taken	before	entry	to	the	event.	Bookings	within	
7	days	of	event	require	payment	on	booking.	Access	to	the	Document	Portal	will	not	be	given	until	
payment has been received.
Substitutions/Name	Changes: If you are unable to attend you may nominate, in writing, another
delegate to take your place at any time prior to the start of the event. Two or more delegates may
not	‘share’	a	place	at	an	event.	Please	make	separate	bookings	for	each	delegate.
Cancellation:	If you wish to cancel your attendance at an event and you are unable to send
a	 substitute,	 then	 we	 will	 refund/credit	 50%	 of	 the	 due	 fee	 less	 a	 £50	 administration	 charge,	
providing that cancellation is made in writing and received at least 28 days prior to the start of the
event. Regretfully cancellation after this time cannot be accepted. We will however provide the
conferences documentation via the Document Portal to any delegate who has paid but is unable
to	attend	for	any	reason.	Due	to	the	interactive	nature	of	the	Briefi	ngs	we	are	not	normally	able	to	
provide documentation in these circumstances. We cannot accept cancellations of orders placed
for	Documentation	or	the	Document	Portal	as	these	are	reproduced	specifi	cally	to	order.	If	we	
have to cancel the event for any reason, then we will make a full refund immediately, but disclaim
any further liability.
Alterations: It may become necessary for us to make alterations to the content, speakers, timing,
venue or date of the event compared to the advertised programme.
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http://smi-online.co.uk/privacy-legals/privacy-policy.	If	you	no	longer	wish	to	receive	email
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Terms	and	Conditions	of	Booking
Please complete fully and clearly in capital letters. Please photocopy for additional delegates.
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events,	please	tick	□
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accounts dePt
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Direct	Tel:	 	 				Direct	Fax:		 	
deLegate detaiLs
venue Sheraton	Boston	Hotel,	Boston,	USA
□ Please	contact	me	to	book	my	hotel
Alternatively	call	us	on	+44	(0)	870	9090	711,	
email:	events@smi-online.co.uk	or	fax		+44	(0)	870	9090	712
conference Prices grouP discounts avaiLabLe
I	would	like	to	attend:	(Please	tick	as	appropriate)	 	 	 TOTAL
□ Conference  Workshop Day $2998.00
□ Conference only $1999.00
□ Workshop Day only $999.00
□ Evening Dinner (Limited	Availability	-	only	available	to	Pharmaceutical	Companies)
ProMotionaL Literature distribution
□ Distribution	of	your	company’s	promotional	
literature to all conference attendees $1598.00		 +	VAT		 $1917.60	
The conference fee includes refreshments, lunch, conference papers, and access to
the	Document	Portal.	Presentations	that	are	available	for	download	will	be	subject	to	
distribution rights by speakers. Please note that some presentations may not be available
for download. Access information for the document portal will be sent to the e-mail
address	provided	during	registration.	Details	are	sent	within	24	hours	post	conference.
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SMi Group's Pre-filled Syringes East Coast 2020

  • 1. PLus tHree interactive Post conference WorksHoPs Wednesday 29tH aPriL 2020, sHeraton boston HoteL, boston, usa HigHLigHts for 2020: • Explore how digital connectivity is being used in the PFS industry • Gain insights into control strategies for DDC developments • Hear key regulatory updates from the FDA and industry experts • Understand how patient centricity is being incorporated into device development • New for 2020: Interactive workshop day cHair for 2020: Michael Song, Senior Manager, Dosage Form Design and Development, AstraZeneca featured 2020 sPeakers incLude: • Tina Kiang, Director, Division of Drug Delivery and General Hospital Devices, and Human Factors, Food and Drug Administration • Alie Jahangir, Senior Manager, Combination Products and Emerging Technologies, Janssen Pharmaceutical • Delma L Broussard, Director, Medical Device & Combination Products PV Expert, CSL Behring • Susan Neadle, Sr. Director, Global Value Chain Quality Design, Head, J&J Combination Products CoP, Johnson & Johnson • Diane Doughty, Senior Scientist, Dosage Form Design & Development, AstraZeneca • Jennifer Hefele Wald, Director Global Regulatory Affairs Devices & Combination Products, Pfi zer • Heather L. Guerin, Associate Director, Regulatory Affairs - CMC, Janssen • Krystin Meidell, Manager, Regulatory Affairs CMC Medical Devices and Combination Products, Biogen • Michael Friedman, Combination Product Lead, Amgen ... And Many More! www.pfsamericas.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 ACADEMIC & GROUP DISCOUNTS AVAILABLE @sMiPHarM #smipfsusa Sheraton Boston Hotel, Boston, USA SMi Group Proudly Present the 7th annual... CONFERENCE: 27TH - 28TH WORKSHOP DAY: 29TH APRIL 2020Innovations in parenteral device and product development Pre-Filled Syringes East Coast A: Combination Product Development – A roadmap for success Workshop Leader: Michael Song, Senior Manager, Dosage Form Design and Development, AstraZeneca 08.30 - 12.00 B: Drug Delivery Device Testing Solutions Workshop Leader: Michael Goehring, Medical & Pharmaceutical Industry Manager, ZwickRoell 13.00 - 15.30 C: How to pass a Human Factors Validation study Workshop Leader: Marc Egeth, PhD, Senior Director, Core Human Factors, Inc. and Pati Anderson, Mse, Senior Associate, Core Human Factors, Inc. 16.00 - 18.20 REGISTER By 13TH DECEMBER AND SAVE $400 REGISTER By 31ST JANUARy AND SAVE $300 REGISTER By 28TH FEBRUARy AND SAVE $200 sPonsored by
  • 2. 08.00 Registration & Coffee 09.00 Chair’s Opening Remarks Michael Song, Senior Manager, Dosage Form Design and Development, AstraZeneca digitaL connectivity in tHe Pfs industry oPening address 09.10 Wearable and digital devices – a hybrid view between pharmaceutical and medical devices • How lessons learned from medical device can help with wearable device development • Electronics, batteries, and IEC requirements – let’s not reinvent the wheel • Testing approach for novel / unique devices Michael Song, Senior Manager, Dosage Form Design and Development, AstraZeneca 9.50 Digital health: The evolving regulatory landscape • Overview of recent changes in regulation and guidance • Case Study: Connected Integrated Injector • Case Study: Sensor/App for Inhaler • Case Study: Dose Calculator App Krystin Meidell, Manager, Regulatory Affairs CMC Medical Devices and Combination Products, Biogen 10.30 Morning Coffee – Sponsored by 11.00 Simulation driven analysis in Product development • Cloud based Numerical simulation. • Scripted simulation to achieve design optimization Lin Li, Senior Consultant Engineer, Delivery Devices and Connected Solutions, Eli Lilly and Company drug Product forMuLation and controL strategies 11.40 Challenges and opportunities in developing a system-wide stability program for combination products • Combination Products • Stability Indicating Attributes • Design Control process • End-to-End Stability • Drug/Biologics- Device Interactions Alie Jahangir, Senior Manager, Combination Products and Emerging Technologies, Janssen Pharmaceuticals 12.20 Consideration for defi ning the administration procedure for nano-dose drug in clinical studies • Adsorption phenomenon • Dose recovery considerations • Mitigation strategies Michael Zhou, Investigator, Pharmaceutical Development- Sterile CoE, gsk 13.00 Networking Lunch 14.00 Technical overview of COP for prefi lled syringes • Key properties of COP • Case Study (New): - Protein Adsorption of Abatacept – COP vs Glass - Immunogenicity test of the aggregates • Case Study: Protein Adsorption of Humira, Embrel, Remicade – COP vs Glass • Case Study: Protein Adsorption with/without Polysorbate (Surfactant) – COP vs Glass • Leachable data on COP syringes Larry Atupem, Sr. Business Development Specialist, Zeon Specialty Materials 14.40 Combination Product Risk Management • Introduction of ICH Q9 and ISO 14971 • Challenges of completing a comprehensive Hazard Analysis for combination products • Design Risk Assessments for off the shelf components • Integrating current drug development risk assessments to meet ISO 14971 compliance Tanner Barnes, Design Control Engineer II, Pfi zer 15.20 Qualifi cation and validation of VH2O2 industrial low temperature terminal sterilizer process and equipment - Case study on process control and monitoring • Brief introduction to VH2O2 sterilization process, technology and applications • Discuss validation and meeting ISO14937 standard requirements - and looking at the scenario of future VH2O2 specifi c standards • Present the essential process variables forVH2O2 sterilization • Case study on testing and comparing performance of various hydrogen peroxide concentration measurement methods – and proposing an applicable approach Juha Mattila, Director, Sterilization Technologies, STERIS Corporation 16.00 Afternoon Tea – Sponsored by REGULATORy OUTLOOK – PART 1 sPotLigHt Presentation 16.30 A regulatory outlook and update of the combination product industry • Affect of TPLC re-organization in CDRH on combination product review (premarket and compliance) • New guidance updates Tina Kiang, Director, Division of Drug Delivery and General Hospital Devices, and Human Factors, Food and Drug Administration 17.10 EU MDR impact on premarket regulatory requirements for combination products • Overview of new requirements of EU MDR Article 117, which could result in signifi cant changes in practice, and potential impact to product development timelines • Collaborations between industry regulatory networks and EMA and Notifi ed Bodies to clarify requirements • Discussion of recognized issues in interpreting Article 117 requirements and potential paths forward to meet new requirements Heather L. Guerin, Associate Director, Regulatory Affairs - CMC, Janssen 17.50 Chair’s Closing Remarks and Close of Day One 18.30 End of Day One Networking Dinner - Invitation Only Register online at www.pfsamericas.com Pre-Filled Syringes East Coast Conference DAy ONE | MONDAy 27TH APRIL 2020 www.pfsamericas.com
  • 3. 08.30 Registration & Coffee 09.00 Chair’s Opening Remarks Michael Song, Senior Manager, Dosage Form Design and Development, AstraZeneca Lifecycle Management for Combination Products OPENING ADDRESS 09.10 Combination products integrated development • Combination Products Regulations are evolving globally  • One consistent undercurrent to this dynamic regulatory environment is the drive for successful practices and control strategies throughout the combination product lifecycle, to assure public health, ensuring risk is commensurate with product complexity and patient needs • In this presentation we’ll review combination products integrated development and risk management considerations and essential performance requirements to support robust product development and lifecycle management Susan Neadle, Sr. Director, Global Value Chain Quality Design, Head, JJ Combination Products CoP, Johnson Johnson 09.50 Combination product lifecycle management • Why is it important to incorporate risk management and design controls into the LCM of Combination products? • How to manage change through design controls • Use of platforms for optimization of development time and costs • Regulatory standards to consider Michael Friedman, Combination Product Lead, Amgen 10.30 Morning Coffee – Sponsored by 11.00 Lifecycle management of combination products - a regulatory perspective • Regulatory’s role in the product change assessments and DHF deliverables • Handling legacy combination products • What should be submitted for legacy and new combination products? Jennifer Hefele Wald, Director Global Regulatory Affairs Devices Combination Products, Pfizer Regulatory Outlook – Part 2 11.40 Regulatory Perspective on Human Factors Requirements for Combination Products • Overview of human factors topics including platform approaches, training programs, and Instructions for use • Importance of risk analysis and risk considerations in development of human factors studies and communication of results • Best practices for incorporating human factors studies results into regulatory filings Heather L. Guerin, Associate Director, Regulatory Affairs - CMC, Janssen 12.20 FDA postmarketing safety reporting for combination products guidance • Reporting requirements for combination products under PMSR final rule • Overview of report types based on constituent parts • Hypothetical examples of report types Delma L Broussard, Director, Medical Device Combination Products PV Expert, CSL Behring 13.00 Networking Lunch Device Development PANEL DISCUSSION 14.00 Combination products evolving trends • What are some of the significant challenges that people face in implementation of combination product regulations? • Is there anything uniquely challenging from a drug-led manufacturer versus a device-led manufacturer? • Can you comment on Post-Marketing Safety Reporting for Combination Products as it relates to risk management? Panel Moderator: Susan Neadle, Sr. Director, Global Value Chain Quality Design, Head, JJ Combination Products CoP, Johnson Johnson Panelists: Jennifer Hefele Wald, Director Global Regulatory Affairs Devices Combination Products, Pfizer Delma L Broussard, Director, Medical Device Combination Products PV Expert, CSL Behring Alie Jahangir, Senior Manager, Combination Products and Emerging Technologies, Janssen Pharmaceuticals Leonel Vanegas, President/Principal, Resmedica 14.40 Latest date of oxycapt multilayer plastic vial syringe • Comparison among OXYCAPT, COP and Glass • Excellent Oxygen Ultraviolet Barrier • Oxidation and Aggregation Studies of Antibody • Development of Staked Needle Syringe Shota Arakawa, Researcher, Mitsubishi Gas Chemical Company, Inc. 15.20 Afternoon Tea – Sponsored by 15.50 Design considerations for optimizing the user experience of prefilled syringes and injection devices • Device features of prefilled syringes and injection devices to support candidate device selection • Design considerations for minimizing pain upon injection • Case study of exploratory clinical study to evaluate injection parameters Diane Doughty, Senior Scientist, Dosage Form Design Development, AstraZeneca 16.30 How quality can help drug-device combination teams become agile in a changing regulatory landscape • The role of quality and CMC during drug-device combination products evolution • Five steps towards becoming agile and flexible anticipating formulation changes before NDA/BLA filings • From pre-filled into a different presentation format after marketing approvals • Life-Cycle Management considerations (e.g. data you’ll need to demonstrate to the regulatory agencies) Leonel Vanegas, President/Principal, Resmedica 17.10 Chair’s Closing Remarks and Close of Day Two Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 Pre-Filled Syringes East Coast Conference Day TWO | TUESday 28th APRIL 2020 www.pfsamericas.com Hear from pharma and regulatory KOLs leading the way in Pre-Filled Syringes Engage in case studies, regulatory outlooks and panel discussions exploring the industry We keep networking at the forefront when it comes to our attendees. Expand your community, benefit from the right people and secure future collaborations
  • 4. Overview of the workshop: As more and more drug products are being developed as combination products, device development plays a critical role. To successfully develop a combination product, it requires collaboration and consideration from multiple angels. In this workshop we will dive into each of these factors from primary container and device selection to how to manufacturing considerations and ways to platform and streamline development activities without running into regulatory risks. Some of the areas we will explore include • Drug product and primary container interaction and impact on device selection and development • How to select the right device and utilizing design control and strategic approaches to minimize development risks and timeline. • Design verifi cation, biocompatibility, extractable and leachables • Packaging and manufacturing consideration • Stability and controls strategy Reasons to Attend: • Learn about interlinked relationship between drug product, primary container, device, and packaging. • Consideration and ways to minimize device development risks • Dive into design verifi cation, biocompatibility, EL, and control strategies • Role packaging play in successful combination product • Process development and consideration About the workshop Leader: Michael Song leads the Device Functionality, Safety and Digital Connectivity group at MedImmune, a Member of the AstraZeneca Group. In his current role, he oversees device functionality; primary container science and technology; biocompatibility; container closure integrity testing; and digital connectivity. Prior to his current role, Michael was head of Device and Package Engineering at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University. Combination Product Development – A roadmap for success Post conference WorksHoP a 08.30 - 12.00 Register online at www.pfsamericas.com Post Conference Workshop Day Wednesday 29th April 2020, Sheraton Boston Hotel, Boston, USA www.pfsamericas.com Workshop Leader: Michael Song, Senior Manager, Dosage Form Design and Development, AstraZeneca Post conference WorksHoP b 13.00 - 15.30 Drug Delivery Device Testing Solutions Overview of the workshop: In the drug delivery device, testing world, the regulatory requirements add complexity to the simplest of test. What occurs when the testing moves from the simple to multifaceted is an exponential amount of effort to meet industry demands. Finding the best partner starts with a full understanding of your internal and external requirements. Uncovering the unknowns is an arduous task but a crucial one to your success. About the workshop leader: Michael Goehring, Medical Pharmaceutical Industry Manager, ZwickRoell BSEE – Instrumentation and Systems – University of Connecticut Field Systems Engineer for materials and component test systems Territory Manager for Laboratory Information Management Systems District and Regional Sales Manager for materials and component test system North America Sales Manager for material preparation and analysis Industry Manager – Medical Pharmaceutical. ZwickRoell has years of experience in delivering innovative solutions for drug delivery systems that reduce operator infl uence, which increases accuracy, repeatability, reproducibility and traceability of test results. Post conference WorksHoP c 16.00 - 18.20 How to pass a Human Factors Validation study Overview of the workshop: Hear expert opinions on how to structure a human factors program from product conceptualization and early design through risk analysis development and iterative usability testing in order to pass a human factors validation study on the fi rst attempt. Reasons to Attend: • Learn how to build and optimize your company’s human factors and usability engineering process and how that can be applied to every development project in order to reduce development delays and improve the chances of fi rst-time success • Discuss the regulatory imperative of HFE, and the focus on use-related harm, as well as other uses of HFE • Discuss how HFE as an RD activity, not a documentation activity • Discuss development and testing of instructions for use (IFU) • Discuss how to scale HFE programs and how programs vary from product to product About the workshop leaders: Pati andMarc manage all aspects of human factors projects at Core Human Factors. Our experience includes hundreds of different types of medical devices and combination products. We have worked on every phase of HF work, run studies all around the world, and helped dozens of different companies manage their HF programs and navigate regulatory pathways. Part of our work includes IFU design, development and testing. Core Human Factors, Inc. (Core) is a consulting group based outside of Philadelphia, PA, staffed by human factors specialists with a wide variety of backgrounds. We specialize in human factors testing for medical devices and health care systems. Core has helped hundreds of products successfully navigate FDA review and gain CE marks, and our researchers have published dozens of publications in peer-reviewed journals. In addition to user testing, we also assist in the design of products, instructional materials, and training programs; risk analyses; user needs documentation; and ideation sessions to facilitate invention and human- centered design in health care and medicine. Programme 16.00 Scaling HFE - Doing More with Less • Regulatory imperative and focus on safety • Time and cost tradeoffs in iterative design • Can you be a biosimilar or generic? • Making changes after a Validation 16.35 Human Factors Protocols that Work • Valid assessments of risks • Non-biasing study designs and interview techniques • Pivoting from a pilot • Pre-submission process 17.10 Instructions for Use, a Human Factors Perspective • Why IFUs should be considered early and often • Initial design • Iterative development • The good, the bad, and the ugly 17.45 Case Studies • Case study #1 • Case study #2 • Case study #3 • Case study #4 Programme 13.00 Drug Delivery Device Testing Overview • Importance of a URS (User Requirements Specifi cation • Functional Design Specifi cation 13.35 (Prefi lled) Syringe testing and spring simulation (power pack) • Glide Force New ISO 7886-1 • ISO 11040-4, -6, -8 • ISO 80369-7, -20 14.10 Auto injector and pen injector testing – wearable device testing • ISO 11608-1 (Pen), ISO 11608-2 (Needle), ISO 11608-3 (Cartridge) • ISO 11608-2 (Needle) • ISO 11608-3 (Cartridge) • ISO 11608-5 (Full Function test on Auto Injectors) • ISO 11608-6 (Wearables) 14.45 Device testing – regulatory demands • 21 CFR Part 11 – Traceability (When, Who, What, Why and Who is Responsible) • DQ, IQ, OQ and why not PQ. MDR Europe 15.20 Session Recap 15.30 Afternoon Tea Workshop Leader: Michael Goehring, Medical Pharmaceutical Industry Manager, ZwickRoell Workshop Leaders: Marc Egeth, PhD, Senior Director, Core Human Factors, Inc. Pati Anderson, Mse, Senior Associate, Core Human Factors, Inc. Programme 08.30 Registration and Coffee 09.00 Session 1 • Primary Containers Components • Drug Product and Primary Container interaction and considerations • Extractable and Leachables 09.35 Session 2 • Device selection and characterization • Considerations from process, manufacturing, packaging, and usability standpoint • Key drivers for success and novel devices 10.10 Morning Coffee 10.30 Session 3 • Process and manufacturing overview considerations (clinical, commercial, and automation) • Packaging considerations and risk reduction • Risk Assessment, Controls strategy and DV testing 11.05 Session 4 • Design Verifi cation and Validation • Stability approaches • Future trends, digital health, wearables, and novel technology 11.45 Session Recap 12.00 Networking Lunch
  • 5. ProudLy sPonsored by: sPonsorsHiP and exHibition oPPortunities SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to compliment you company’s marketing strategy. Prime networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specifi c to your industry. Should you wish to join the increasing number of companies benefi ting from sponsoring our conference please call: Alia Malick, Director, on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk Marketing oPPortunities Want to know how you can get involved? Interested in promoting your services to this market? Contact Jinna Sidhu, Marketing Manager, +44 (0) 20 7827 6088 or email: HSidhu@smi-online.co.uk Pre-Filled Syringes East Coast Conference www.pfsamericas.com Register online at www.pfsamericas.com Aptar Pharma is a leading provider of innovative drug delivery systems to pharmaceutical, consumer healthcare and biotech customers worldwide, enabling safe, convenient and compliant medication delivery. Trusted partner of the pharmaceutical community, we provide our customers with a large range of specialized drug delivery devices, components and analytical services backed by decades of proven expertise. We have broad therapeutic expertise in Nasal, Pulmonary, Injectables, Eye Care and Dermal delivery routes, among others. Our global manufacturing footprint of sites in Argentina, China, France, Germany, India, Switzerland and the U.S. provides security of supply and local support to our customers. www.aptar.com/pharma Credence MedSystems is an innovator in injectable drug delivery devices. Credence’s philosophy of Innovation Without Change results in products that impress and protect end-users while preserving pharma’s existing processes, sourcing strategies and preferred primary package components. The Companion® family of syringe systems includes proprietary needle-retraction technology, reuse prevention and other critical safety and usability features in Staked and Luer needle formats. The Dual Chamber platform offers single-step mixing and injection for drugs requiring reconstitution at the time of delivery. Additional products such as metered dose devices, multi-length staked needles and other novel devices address the needs of specifi c therapeutic markets. www.credencemed.com Mitsubishi Gas Chemical is a leading company in the fi eld of oxygen barrier and absorbing technologies. Based on these technologies and experiences, we have successfully developed multilayer plastic vial and syringe having excellent oxygen, ultra violet and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs. www.mgc.co.jp/eng/products/abd/oxycapt.html Polyplastics is the leading maker of TOPAS COC (cyclic olefi n copolymer), a glass-clear, incredibly pure, break-resistant plastic for drug delivery, including syringes, vials and cartridges. The benign COC medical polymer presents a nonreactive surface for advanced molecules. Additionally, TOPAS COC offers high moisture and chemical resistance, barrier and UV transmission. https://topas.com STERIS Life Sciences is your trusted partner in contamination control. For over 100 years, STERIS has been a global leader and expert in the industries of sterilization, cleaning and infection control. Today, we continue to build on this heritage by providing the products and resources you need throughout every step of your process. From innovation to results, our comprehensive portfolio of products and services is designed to meet your needs. With offi ces located worldwide and technicians in over 100 countries, you can count on us to be where you are when you need us, every step of the way. Trust STERIS Life Sciences to help you create a healthier and safer world. www.sterislifesciences.com The Weiss-Aug Group is your global partner for the design support, development, engineering and manufacture of medical devices and drug delivery components and sub-assemblies. With specialized knowledge and state-of-the-art equipment, The Weiss-Aug group delivers the latest technologies for Disposable Safety Products, Drug-Delivery Products, Orthodontics, Ophthalmic Disposables and Devices, Electrosurgery. www.weiss-aug.com/ ZEON’s Zeonex® and Zeonor® cyclo olefi n polymer (COP) allow for advanced, break-resistant syringes, vials and lyophilization containers for protein-based biopharmaceuticals, high viscosity drugs, and contrast media. They also offer high purity, “glass-like” transparency, sterilization, low water absorption, and superior moldability, as well as overcome protein adsorption and ph shift concerns. www.zeonex.com ZwickRoell manufactures and supports a wide range of materials testing machines, systems and accessories for use in research, quality control, production environments and academia. Our extensive portfolio of testing machines and accessories cover almost every segment, from medical and pharmaceutical packaging to surgical instruments and orthopaedics and biomaterials. www.zwickroell.com Pre-Filled Syringes East Coast Past Attendee Breakdown 110+ Industry professionals from Europe and beyond 7+ Dedicated hours of networking Business Development Manager 22% Senior Engineer 21% Director 17% Project Manager 15% Senior Device Manager 12% Senior Principal Scientist 13% Breakdown of attendee - Job function suPPorted byofficiaL Media Partner key Media Partners Attendee Geography: USA 78% Europe 12% United Kingdom 4% Asia Pacifi c 2% Africa 1% Canada 3% Pre-Filled Syringes Series save tHe date Conference: October 2020 Sheraton Boston Hotel, Boston, USA Wearable Injectors and Connected Devices USA Conference: 15th - 16th June 2020 Hyatt Regency Mission Bay, San Diego, CA, USA Pre Filled Syringes West Coast Conferences: 14th-15th September 2020 San Francisco, USA Pre Filled Syringes San Francisco neW for 2020 neW for 2020
  • 6. PRE-FILLED SyRINGES EAST COAST 2020 Conference: Monday 27th Tuesday 28th April 2020, Sheraton Boston Hotel, Boston, USA Workshops: Wednesday 29th April 2020, Sheraton Boston Hotel, Boston, USA 4 WAyS TO REGISTER www.pfsamericas.com fax your booking form to +44 (0) 870 9090 712 PHone on +44 (0) 870 9090 711 Post your booking form to: Events Team, SMi Group Ltd, India House, 45 Curlew Street, London, SE1 2ND, UK If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk Unique Reference Number Our Reference P-315 docuMentation I cannot attend but would like to Purchase access to the following Document Portal/ Paper Copy documentation. Price Total □ Access to the conference documentation on the Document Portal £499.00 + VAT £598.80 □ The Conference Presentations – paper copy £499.00 - £499.00 (or only £300 if ordered with the Document Portal) Payment must be made to SMi Group Ltd, and received before the event, by one of the following methods quoting reference P-315 and the delegate’s name. Bookings made within 7 days of the event require payment on booking, methods of payment: □ uk bacs Sort Code 300009, Account 11775391 □ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU Swift (BIC): LOyDGB21013 IBAN GB75 LOyD 3000 0911 7753 91 □ Cheque We can only accept US Dollar Cheques drawn on a US Bank. □ Credit Card □ Visa □ MasterCard □ American Express SMi Group will apply surcharges to commercial cards Please tick here □ if the card provided is not a commercial card Card No: □□□□ □□□□ □□□□ □□□□ Valid From □□/□□ Expiry Date □□/□□ CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card Cardholder’s Name: Signature: Date: I agree to be bound by SMi’s Terms and Conditions of Booking. 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Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another delegate to take your place at any time prior to the start of the event. Two or more delegates may not ‘share’ a place at an event. Please make separate bookings for each delegate. Cancellation: If you wish to cancel your attendance at an event and you are unable to send a substitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providing that cancellation is made in writing and received at least 28 days prior to the start of the event. Regretfully cancellation after this time cannot be accepted. We will however provide the conferences documentation via the Document Portal to any delegate who has paid but is unable to attend for any reason. Due to the interactive nature of the Briefi ngs we are not normally able to provide documentation in these circumstances. We cannot accept cancellations of orders placed for Documentation or the Document Portal as these are reproduced specifi cally to order. If we have to cancel the event for any reason, then we will make a full refund immediately, but disclaim any further liability. Alterations: It may become necessary for us to make alterations to the content, speakers, timing, venue or date of the event compared to the advertised programme. Privacy policy / Opt Out: For full details on our privacy policy please go to http://smi-online.co.uk/privacy-legals/privacy-policy. If you no longer wish to receive email updates you can opt out by going to the following webpage http://www.smi-online.co.uk/opt-out Terms and Conditions of Booking Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Title: Forename: Surname: Job Title: Department/Division: Company/Organisation: Email: If you would like to continue to receive email updates about our events, please tick □ Company VAT Number: Address: Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: Mobile: Switchboard: Signature: Date: I agree to be bound by SMi’s Terms and Conditions of Booking. accounts dePt Title: Forename: Surname: Email: Address (if different from above): Town/City: Post/Zip Code: Country: Direct Tel: Direct Fax: deLegate detaiLs venue Sheraton Boston Hotel, Boston, USA □ Please contact me to book my hotel Alternatively call us on +44 (0) 870 9090 711, email: events@smi-online.co.uk or fax +44 (0) 870 9090 712 conference Prices grouP discounts avaiLabLe I would like to attend: (Please tick as appropriate) TOTAL □ Conference Workshop Day $2998.00 □ Conference only $1999.00 □ Workshop Day only $999.00 □ Evening Dinner (Limited Availability - only available to Pharmaceutical Companies) ProMotionaL Literature distribution □ Distribution of your company’s promotional literature to all conference attendees $1598.00 + VAT $1917.60 The conference fee includes refreshments, lunch, conference papers, and access to the Document Portal. 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