Seminar: North American Market Access

North American Market Access Seminar June 20 & 21, 2023 Copenhagen, denmark

The Danish Trade Council is proud to offer this in-person seminar in Copenhagen to support Danish MedTech SMEs entering the North American markets.

Stakeholders and leading industry experts with deep knowledge and experiencewiththeUSand Canadian markets willprovidevaluablecontenton specificaspectsofmarketaccesswithaparticularfocusonreimbursement.

The seminar has been developed through discussions with leading industry expertsandbasedonfeedbackfromDanishSMEs.

Value proposition background

Denmark's life science sector offers innovative solutions to global health-care challenges, and North America is a crucial trading partner for Danish companies in this industry. The US is the largest market, with $7.45 billion in Danishlifescienceexportsin2020.

However, Danish SMEs face significant obstacles to entering these markets due to complex regulatory requirements, reimbursement processes, distributionchannels,andentityestablishmentrequirements.

Without adequate know-ledge and resources, companies may miss out on potentialearnings.

North

Access

American Market

Seminar

PROGRAM – DAY 1

TUESDAY June 20

8:30 - 9:00

Arrival & Breakfast

9:00 – 10:20

Session #1

WelcometoNorth America!

10:20 – 10:35

Coffee break

10:35 – 13:00

Session #2

UnravellingtheComplexUS Reimbursement Pathway

13:00 – 13:30

Lunch

13:30 – 14:30

Session #3

SoYou’reComing toCanada,Eh?

15:00 – 15:20

Coffee break

14:45 – 16:45

Session #4

TheRegulation ofMedicalDevices in North America

16:45 – 17:00

Session #5

Working withTCtoentertheNorth AmericanMarket

17:00 - 19:00

Networking event

Session OpeningandWelcome Remarks

IntroductiontoUS&CanadianMarkets

DanishMedicalDeviceCompanies ThatHave SuccessfullyEntered theNorthAmericanMarket: CaseStudies

ClassificationofMedicalDevicesinNorthAmerica

IntroductiontoProcurementandReimbursement Processes forMedicalDevicesintheUS Market

Reimbursement CodingSystems (CPT,ICD-10-PCS& HCPCS)for MedicalDevicesintheUSMarket

Reimbursement Processes forMedicalDevicesinthe CanadianMarket

USandCanadianRegulatoryLandscape: CurrentState

Developing aRegulatory Strategyfor theNorth AmericanMarket(SAP/Breakthrough Device Program/eSTeP)

Generation ofClinicalData/EvidenceforMedical DeviceApproval intheNorthAmericanMarket

DenmarkinNorthAmerica–Partnerships with DanishCompanies EnteringNorthAmerica

PleaseNote:theprogram istentativeandmaybesubject tochange

PROGRAM – DAY 2

wednesday June 21

- 8:30

&

8:30 – 11:00

Session #6

KnowBeforeYouGo: Avoiding

Common PitfallsandPreparingto FilewithRegulatory Agencies

FilingaSubmission withRegulatory Agencies in NorthAmerica:OverviewandProcess

RegulatoryConsiderations Around AI/ML/Software as aMedicalDeviceintheNorthAmericanMarket

Commonpitfallstoavoidwhen enteringtheNorth AmericanMarket 11:00 – 12:45

Duringthesesessions, participatingcompanies will havetheopportunity tohaveaone-on-one meeting withNorthAmericanmarketaccessexperts. 12:45 – 13:15

Meeting Session #1 1:1

13:15 – 15:00

Meeting Session #2

1:1Meetings

Duringthesesessions, participatingcompanies will havetheopportunity tohaveaone-on-one meeting withNorthAmericanmarketaccessexperts.

Arrival

8:00

Breakfast

Meetings

Lunch

PleaseNote:theprogram istentativeandmaybesubject tochange

Participation fee & details

ForonlyDKK2200(+outlays forfood/beverages)perorganization* youcansenduptotwoattendeestothisexcitingevent.

*Requires that you meet the criteria for an SME; Less than 250 employees; annual turnover not exceeding DKK 375 million and/or an annual balance sheet total not exceeding DKK 320 million in the last financial year; If owned by a parent company/companiesbymorethan49%and/orhasasubsidiary/subsidiarieswith anownershipinterestofmorethan49%,thenumberofemployeesandrevenuefor thewholegroupmustbeincluded.