LAUNCHING A FIRST PRODUCT IN EUROPE: THE SUPPLY CHAIN ...

LAUNCHING A FIRST PRODUCT IN EUROPE: THE SUPPLY CHAIN PERSPECTIVE

Webinar Panel Discussion Summary

On October 27, 2021, AIM hosted a webinar that was primarily designed for emerging biopharma companies considering an initial launch in Europe. Specifically, the webinar focused on designing and implementing supply chains for launch. The webinar was hosted in partnership with Fierce Markets, publisher of the Fierce Pharma and Fierce Biotech newsletters.

The one-hour webinar included a brief presentation to establish context, followed by a panel discussion. This document provides a summary of the event. It does not provide a verbatim transcript. Panelists’ comments have been paraphrased for flow and brevity. However, significant efforts have been made to ensure that the speakers have been summarized accurately, and each speaker has reviewed and approved this summary.

Moderator:Pim Van Der Aar:

Panelists:Christian Ellereit:

Ronald van Zitteren:

Joop Wijdeven:

Co-Founder & Managing Director, AIM

Head of Finance, Europe, Travere Therapeutics

Principal, AIM

Associate, AIM

2© Blue Matter Consulting, Inc

https://aimconnection.eu

https://www.fiercepharma.com

https://www.fiercebiotech.com

Pim Van Der Aar:

Good morning, good afternoon, and good evening. It is my pleasure and honor to welcome you to the first webinar hosted by AIM and Fierce Markets. Today, we will be talking about launching a first product in Europe, and we’ll be looking at this through the supply chain lens.

First, a few opening statements before we dive into the details. The first statement is pretty obvious. If you cannot get your product to patients or reimbursed, then your launch has failed. So an efficient supply chain is fundamental.

Building a supply chain is also complex. We usually say it’s not “rocket science” but indeed, there are many factors to consider, which we will dive into later. The details make it complex.

A thorough understanding is needed. A company can’t just jump into action mode without first doing a thorough analysis of what its supply chain should look like. What do your patients need? What about your prescribers, payers, and other stakeholders? Once those things are determined, then it’s time for action mode.

INITIAL PRESENTATION

• An efficient supply chain is fundamental to the success of a first launch in Europe.

• Building a supply chain is complex, with many local factors to consider.

• A thorough understanding and analysis is imperative for success.

• Unfortunately, supply chain issues are often overlooked in early planning.

• Today, we discuss key aspects of creating a life science supply chain in Europe.

Abstract


Unfortunately, some companies start off a little late—or too late—to properly design and build their supply chains.

As you can see here, there are many things to consider in Europe.

We usually talk about the “software” side and the “hardware” side of launch. The “software” side is very much focused on the product itself: the product strategy, approval, access and reimbursement, market preparation, and so on. Those are all things we are not going to talk about today. On the “hardware” side, the people and infrastructure are the key concerns. Of course, our focus today is on the people and infrastructure related to the supply chain and the associated finance requirements.

So, today, we will have this short presentation. Then, we will have the panel discussion. Finally, we will have time to answer some questions from the audience.

COMPLEXITIES OF EUROPEAN LAUNCH

"Software" "Hardware"

Supply Chain and Distribution

Finance

Our FocusMany things to think of when launching into Europe:

• Corporate and Portfolio Strategy

• Opportunity Assessment and Valuation

• Market Entry Strategy

• Medical Landscape Assessment

• Integrated Evidence Planning • KOL and Community

• Engagement Strategy

• Market Access Landscape Assessment

• Market Access and Pricing Strategy

• Value Communication and Engagement

• Commercial Landscape Assessment

• Brand Strategy and Commercial Model

• Launch Strategy & Planning

• Organizational Design & Development

• Talent Development

• Training

• Infrastructure Plan

• Supply Chain and Distribution

• Site Selection

• Finance

Strategy Access People

InfrastructureAdoptionAuthorization

1

2


OUR TOPICS FOR THE EU & GREATER EUROPE

Some of the key topics we will cover include:

As you can see on the map of Europe, that little green blob in the middle is Switzerland. It’s not a member of the EU, which implies a separate marketing authorization. Shipping out of the EU into Switzerland is considered a true export, and you would need to take the necessary precautions to make that happen. You’ll also notice our friends across the North Sea, the UK. Now they also require a separate authorization procedure and shipments to the UK are also considered exports from Europe. Up top, you’ll notice Norway. They are a bit of a hybrid. They do follow the EU guidelines but they are not part of the EU and shipments to Norway from Europe are considered exports.

There are a few basic distribution models to consider.

• Key success factors

• Most common pitfalls and mistakes

• Best practices

• Timing of major preparations

• What to outsource vs. in-source

• Key financial issues and

• Regulatory issues (though not those related to the EMA or marketing authorizations); We’ll focus more on the local licenses, manufacturing and selling licenses that are required to operate in Europe.

• Key success factors

• Most common “pitfalls” or mistakes

• Supply chain best practices

• Timing of major preparations

• In-sourcing vs. out-sourcing

• Key tax and financial issues

• Major regulatory requirements

Short Presentation1

Panel Discussion2

Audience Q&A3


The first is a centralized model that quite often uses a central warehouse or third-party logistics provider (3PL) located in the vicinity of Belgium, the Netherlands, or Germany. Out of the central location, a company can ship out to the rest of Europe. There are some restrictions in some companies with this type of model, but 80% of the time, it’s workable.

In the middle, there is a regional model. This involves warehouses or 3PLs in various regional locations. On the right is the local model, in which a company sets up a local warehouse in every country in which it sells.

So, today, we’re going to talk about a range of supply chain topics. To set up our panel discussion, let’s assume you have a product. It’s got packaging, it’s serialized, and it’s tested. But, how do you get it into the EU? How do you get a Qualified Person (QP) release (which is mandatory)? From where do you sell? Do you have one selling entity or more? To whom do you sell? Connected to that, how do you invoice? Also, how do you organize to implement your supply chain?

DISTRUBUTION MODELS USED IN EUROPE

Central Regional Local

One warehouse serving entire customer base, ideally located

with excellent transportation links.

Shipments Direct-to-Hospital are possible in each geographic model but may not be possible in each individual EU country due local market practices. Hospitals are here invoice-to parties. Retail pharmacy products tend to go via wholesaler though exceptions are possible

Several regional warehouses serving multiple markets.

Single warehouse and logistics operations per market.


KEY QUESTIONS RE: EU DISTRUBUTION & FINANCE

Let’s meet our panelists.

Christian Ellereit Joop Wijdeven Ronald van Zitteren Pim van der AarSenior Director Finance

Europe Travere TherapeuticsAssociate

AIMPrincipal

AIMCo-Founder

AIM

• Head of Finance, Europe at Travere Therapeutics, a US-based biopharma company focused on rare diseases

• Plays a key role in establishing Travere’s European commercial organization

• Other experience includes Santhera Pharmaceuticals, InterMune, and Alcon Laboratories

• Early career as an IT consultant specializing in supply chains

• Held management positions of increasing scope at a large multinational pharma company

• Has helped many biopharma companies enter Europe: involvement has ranged from strategic design through implementation and expansion

• Substantial background in biopharma and consulting

• Senior management positions in four global companies, including UCB and Amgen

• Primary focus on supply chains over 25+ year career

• Other experience includes sales, marketing, change management, and continuous improvement

• Co-founder and Managing Director of AIM

• Focused career on European operations and supply chains

• Prior to AIM, served in key leadership roles at Chiron / EuroCetus and Amgen

• Widely recognized speaker at biopharmaceutical supply chain conferences worldwide

But first:

And then:

How to organize:

• Where & by whom do I produce DS & DP?

• Where do I perform secondary packaging?

• How do I serialize?

• Where do I test?

• How do I import into the EU?

• Where, how & by whom do I perform QP (Qualified Person) release?

• Where do I store un/released product?

• What to outsource & what in-house?

• What (local) licenses are required to operate the model?

• What (local) resources/capabilities are required to operate the model?

• How do I manage and oversee operations?

• How do I obtain mandatory & management reports

• What do I report to whom & how frequent?

• How do I sell? One EU sales entity (Master Distributor) or through local offices (Limited Risk Distributors) (LRD)

• From where do I sell?

• To whom do I sell: hospitals, pharmacies, wholesalers, distributors?

• How do I perform customer service?

• How do I invoice?

• How do I perform cash collection?

• Who performs dunning?

• How about treasury?

How do I create a reliable, efficient, scalable European operational infrastructure?

EU Distribution:


Pim:

Christian, you have been through the adventure of launching in Europe a couple of times. Can you tell us a little about what it’s like launching a new product and a new company in the EU?

Christian Ellereit:

It’s great fun, but it’s a marathon rather than a sprint. It’s important to have a good team in place that’s able to wear different hats, meaning that they are not shy to take on responsibilities that are not directly in line with their job descriptions. There must also be a strong team spirit.

An early start is also key. Start with getting core management teams in place 24 to 36 months ahead of launch. Get complex supply chain development in motion, with supply chain and tech-ops expertise on board early.

Pim:

Speaking of timing, Joop, perhaps you can elaborate a bit on when you would need to start the critical preparations for an EU launch.

Joop Wijdeven:

I think it’s important to ensure your CMC (Chemistry, Manufacturing, and Controls) is in place early and that your product packaging has been addressed. We need to remember that some activities need to happen before submission and some before launch. So, we state that you generally need to start at least 24 months before launch and roughly a year before submission.

The initial critical elements, which should be a part of your submission, are your packaging elements, the design of your artwork, and your QP (Qualified Person) strategy. These elements should start at least a year before submission.

Pim:

Christian, for a company that’s keen to move to Europe, what options do they have from a supply chain standpoint?

Christian:

That’s a complex, difficult question. First of all, it depends on what kind of product you have. For example, do you have a “mass market” product or do you have a rare disease product that only moves 100 units per day?

It also depends on whether you want to go full-scope in Europe and sell in all member states or whether you want to use a hybrid approach, meaning that you perhaps focus your efforts on the top five markets and leave the rest to partners. Of course, some companies can decide to use partners for everything. Furthermore, it depends on whether your product is best suited to a central, regional, or local distribution model.


So, basically, the answer is: It depends. Lately, however, I’ve been a big fan of the centralized approach, primarily because of the expanded capabilities of 3PLs. You can use one selling entity and a centralized distribution hub to serve the patients. But this is best used with a rare disease or a non-mass-market product.

Joop:

A company’s choices also relate to its risk tolerance, when it gets clinical data, and when it can know with some certainty what the market size and opportunity will be. Some companies will build up supply chain—and other—infrastructure early, banking on positive clinical data. Others might rely heavily on contractors initially, to avoid building a lot until they are more certain. You can outsource QP and many supply chain functions, bringing them in-house when it’s safer to do so. A lot depends on the risk profile of the product and the company.

Pim:

Thanks, Christian and Joop. Ronald, not to scare people off, but can you tell me some things that can go wrong when setting up supply chains?

Ronald van Zitteren:

Yes, let me try to focus on four:

1. It’s important to really understand your patients, who they are, and how the product gets to them. Related to this, it’s important to understand the “last mile” to the patient. Will product always be dispensed in a hospital or will it start in a hospital and then move to the pharmacy because of daily use after the patient goes home? These characteristics, combined with others like temperature requirements, product stability, daily home use vs. injection every two weeks, etc. all weigh in. Failing to properly account for items like those in the supply chain development process is a key mistake.

2. Second, don’t neglect the licenses. We’ve seen lead times for licenses grow much longer due to COVID. A lot of our clients get nervous about that and are now seeking “Plan B” or even Plan C or D because of delays in getting licenses! So, be very aware that timelines are longer, and don’t wait.

3. Next is artwork. Improper artwork is known as a major source of recalls. Setting up artwork for European launch is very complex. There can be many iterations, and you must be ready for this. You will need to coordinate your packaging site, your serialization requirements, your local requirements for blue box information, and more. It’s all very complex, and you really need to bring on specialized expertise for that. It’s a key mistake to underestimate the challenge of developing good artwork.


4. A fourth topic I want to mention is not having the right local knowledge on board on time. This can include the local general managers (GMs), the medical science liaisons (MSLs) who are prepping the market, and others. Local “intel” is critical. If you bring them in too late, you may end up needing to redesign parts of your supply chain.

I’ll leave it at those for now.

Pim:

Not to dwell on it too much, but you mentioned the licenses. The MIA and WDA are two important ones. Perhaps you can explain to the audience what these licenses are.

Ronald:

Yes, the MIA is the Manufacturing and Importation Authorization. This allows you to bring product into Europe or manufacture it in Europe under GMP (Good Manufacturing Practices). That is a must in Europe, either in your own company’s name or via a business partner.

The WDA is the Wholesaler Dealer Authorization, which is a distribution license. This allows you to sell the product in Europe as a whole. It also has different names in different countries. You generally need one for Europe, but some countries also require their own versions on top.

Pim:

OK, thanks very much, Ronald. Joop, on the positive side, could you tell us about the key success factors for launching a product in Europe, related to supply chains?

Joop:

As we’ve mentioned already, you have to start the critical elements early. Ronald referred to the artwork and to the licenses. Those are both extremely important.

You also need to be flexible. You will make plans, but circumstances are likely to change, timelines may change, and you need to be able to shift accordingly.

It’s also very important for key roles to have the local knowledge in place, whether it’s internal or via consultants. You need to be able to relate to the local marketplace.

Pim:

Excellent. Christian, let’s say I’ve made up my mind to go to Europe. Who helps me? What kind of assistance is there and how do I go about getting it?


Christian:

My learning is to get a first-class partner on your side. If you go cheap at the start, you will end up paying double. Ideally, get a key partner in each of the major functions. For example, for supply chain, go with someone like AIM. For finance, go with one of the “Big 4” firms. Choose a partner for each function, and ensure a one-to-one relationship for each.

Pim:

OK. Ronald, continuing in that direction, when setting up your supply chain in Europe, what type of expertise do you need next to you to be successful?

Ronald:

I would say that on our projects, in the initial phases, we collaborate with the technology and finance teams the most. It’s very much about what selling model will be chosen, and the implications for the broader organization.

We then begin engaging more heavily with regulatory experts on artwork and other issues. There also has to be a strong interface with the quality control team.

Accounting and Finance are very important throughout. There’s also a lot of coordination with them in the later phases as we set up to take and manage orders, select a 3PL, develop documentation for writing invoices, and so on.

Joop:

I’ll add that for some functions, it’s OK to work with a more generic European consultancy. However, when talking about local licenses (for example), the specialized local knowledge is very important. So, a company is likely to need a combination of supporting experts, including a pan-European consultancy and a perhaps range of local experts…At least, that’s our experience.

Ronald:

I fully agree.

Pim:

That’s great, thank you. Christian, now that we know about the expertise required, when should we think about hiring these people and getting this expertise on board?

Christian:

This is a difficult one because, as I mentioned before, some companies are rather brave. They know (or strongly believe) they have good data and they hire early. Others are very careful and wait. It all depends on the company’s cash situation and risk appetite.


In my experience, though, you ideally hire the key management team 36 months before launch, though 24 months could be OK. By then, you really need to have the European GM, medical affairs leadership, finance people, as well as supply chain and tech ops on board. The marketers are also important, but could wait a little longer.

A lot of this depends on the sequence of launch and which countries will go first. My learning is to hire the individual country GMs 12-15 months before launch. Three months later, the country-level medical personal can come on board. Marketers and Key Account Manager (KAMs) can come 6 months before launch.

Pim:

Thanks, Christian. Ronald, once a company has made the decision to go to Europe, what is the process for building a supply chain? You talked about the “Last Mile” earlier. Perhaps you elaborate on that?

Ronald:

First, you need to ensure that your filing process is in order and running so that the timing of your EMA filing is properly aligned ahead of your expected approval and launch date.

You must also select your site for secondary packaging and start an ongoing effort to prepare it for action. Other licenses need to be identified and initiated, as well.

Then, we would recommend starting a “Last Mile Study.” This is really a deep dive into the product’s “last mile” in key countries because, in the end, the differences between these countries have strong implications for how you set up your supply chain.

We do this study by interviewing key individuals to capture in detail how the product is prescribed, who keeps stock and how, the fulfillment processes, how the money is handled, and how things will change (for example, therapy may initially be started in the hospital and then transitions to a general practice environment after the patient is discharged). A lot of detail comes out of this process that is useful for the supply chain design.

Based on these findings, the next step is to move to the supply chain design. You tend to look at the product flows, financial and title flows, define a couple of model scenarios, and then work with the company to validate the desired distribution model.

In the next steps, we work to identify, evaluate, and select partners. These could be 3PLs, wholesalers, and others. We outline the selection process, develop and send RFPs / RFQs and help with the selections and the checking of qualifications and often also the GDP audits and contracting.

Finally, you move to the implementation phases six to nine months before launch. So, it’s a roughly a five-step process to prepare for daily operations.


Pim:

Thanks very much, Ronald. Christian, anything to add to this?

Christian:

I think there are two elements I can add:

1. Regular follow-up with clear responsibilities: You can do it with the RACI model, flowcharts, or whatever. Don’t be shy about naming the people responsible for key deliverables and setting deadlines. It’s a complex project and if you don’t follow up and do regular check-ins, it can easily fail.

2. You need to fully nail down the product, financial, and title flows. We mentioned it a little while ago. You need to have them validated because you may be able to benefit from tax rules/holiday and to be able to apply in time for needed registrations (VAT, WDL etc.)

3. Spend appropriate time deciding where to set up your selling entity because this can also have significant implications on taxes and licenses, for example.

Joop:

Just one more thought: Often, you see that companies, as a general rule, will conduct their EU launch about one quarter after the US launch. So, there’s a lot of focus on the US, which is understandable for a US-based company. However, you need to make sure you have people who are dedicated and focused on the EU and can make decisions in parallel with the US. You can’t short-change the EU effort by not giving it the proper attention.

Pim:

Thanks, Joop. So maybe we can go down the supply chain step by step and see how we should tackle the various areas and challenges. Starting with packaging and artwork: Ronald, a question which comes up often is should we do secondary packaging in Europe or should we do it elsewhere else (like in the US)?

Ronald:

My first advice is usually to do it in Europe because of the complexities of Europe. However, there are reasons that a company might prefer to start in the US and then bring secondary packaging to Europe later.

If volumes are small or if time is extremely short, then perhaps you can move forward without a European site. But in the majority of cases, it’s done in Europe. A hybrid approach is also possible, which provides a back-up option.

Pim:

In Europe, we have all these languages. Do you need a separate SKU for each country?


Ronald:

Generally speaking, you can combine languages as long as the space on the packaging allows it. With serialization, that takes more space, but combinations are still possible. In most cases, we see two to three languages or countries addressed on a single pack. We rarely see more than three.

There are countries where you need a separate SKU, like Italy, because they have a different system for serialization (until 2025).

Joop:

To add a little detail: What you do comes down to:

1. The space you have on the packaging

2. Local requirements

People are aware that there is a so-called “blue box” where countries can specify local requirements. It has all become more complicated because of the serialization that’s now required in Europe. There are some common combinations and practices in packaging:

• The Nordic countries are a common combination.

• Germany and Austria are also commonly combined.

• France is complicated because of the serialization requirements.

• The UK is usually a separate pack because they’ve stepped out of the European serialization initiatives.

There are a number of logical combinations that can be driven by commercial considerations. Because of the complexities associated with all this—and the serialization requirements—it’s very rare for a biopharma company to use a packaging partner and a 3PL that are the same firm.

Pim:

I understand I need a 3PL in Europe. Let’s say I’m familiar with 3PLs in the US, but not Europe. Ronald, can you compare 3PLs in Europe and the US and what they provide? Also, can you leverage work done in the US to help in Europe?

Ronald:

No, that’s a long shot. European 3PLs exist within 3 tiers:

1. Some claim to serve all of Europe out of one place (pan-European)

2. The 2nd tier offers more regional or local models

3. The 3rd tier is local only (not international)


In the US, the top 3PLs (McKesson, ICS, etc.) are more advanced on the IT side, reporting, and drop-shipment / order-to-cash types of approaches than the Europeans. In Europe, the focus is more on warehousing and distribution than order-to-cash.

We know that McKesson tried to buy business in Europe but had to pull back after a couple of years. We’ve seen Owens & Minor get into Europe, but they also turned back. So, we don’t see single 3PL firms that are successful in both parts of the world.

Joop:

In the US, the 3PLs often take title before selling, so they take away all of that order-to-cash complexity, which is something the European 3PLs typically do not do. In the US, they will handle a lot of the payer complexity, which is less relevant in Europe.

On the other hand, in Europe, the language requirements for customer service, the transport requirements, the different currencies, the different VAT rates, and other factors make things more complex than in the US.

Pim:

Ronald, what is your recommended process for selecting a European 3PL?

Ronald:

You start by deciding the scope of service that the biopharma company will need. This requires an assessment of what should be done in-house vs. outsourced. The next step is to outline the required specifications and to develop the RFP.

You might send the RFP to a maximum of five companies depending on the scope and the time available. After analyzing the responses, you will typically narrow the field down to two potential 3PL partners.

Then, it’s good to do a little road trip to view the sites. You’ll need to see how the goods will be stored, how good the facilities are, etc. It’s very important to look into the eyes of the service providers and see if there can be a connection, if you can build trust from the first day onward and whether they have a true appetite.

Then, out of a process of financial analysis, quantitative and qualitative analyses, etc., a preferred candidate will emerge. We typically use rating charts with different weights on various attributes to score potential candidates.

Once the preferred candidate is selected, you move through the letter of intent, scope of work documents, and the final terms and conditions and other details.


Pim:

Thanks, Ronald. So, now I think we should move to the audience’s questions. One that came in is about this QP release and how that’s organized. Maybe Joop can take us through that process?

Joop:

The QP—or Qualified Person—is an EU-specific role. It does not have an analogue in the US. The QP personally releases the product to the market and is personally accountable for its quality.

That starts before the submission. The QP provides a QP declaration which guarantees the GMP compliance for the active substances used in the product. Before releasing actual product into the market, the QP has to audit and qualify the complete supply chain up to secondary packaging. All the steps in the supply chain have to be qualified by the QP, who will not release product until that is done.

The QP needs to release each batch individually. For emerging US-based companies operating in Europe, there will be significant cooperation between the EU QP and the US-based quality team.

The QP has independent decision-making authority and independent responsibilities in cases of recall. It’s a very strong, formal role.

There are basically three approaches a company can use for this. You can:

1. Set up your own manufacturing license and use your own QP.

2. Work with a contract QP. In this case, you’ll still do the release in your own company’s name from your own entity, which means you will need an MIA license, which requires your own quality management system and a lengthy licensing process.

3. Do the QP and releases through a partner. This approach is often used by small companies, at least initially. In this case, a specialized partner holds the license and they are the releasing company. They would be listed in your product information (on your package insert) as the manufacturer. Small companies can start off this way, then move to an internal QP and MIA license later. It all depends on the company’s strategy and risk profile.

If you have your own manufacturing license, then you don’t need a separate distributor license. Also, even though there is one set of EU rules, the interpretations vary across countries. It gets very complicated, so that’s as deep as we can go for now.

Pim:

Thanks, Joop. A question for you, Christian, with regards to your 3PL: Are there any tax implications regarding where your 3PL is located?


Christian:

Yes, indeed there can be. It goes back to really understanding your product, financial, and title flows and then working with your partners on local regulatory requirements and licensing needs.

In some countries, when you import products you need to pay import fees and value-added taxes and in some later months you get them back. For companies short on cash, that can be a problem for cash flow.

So, you really need to work with the right expertise to see where your product is going, what licenses and registrations you’ll need. It also takes time to apply for these licenses. There’s also the question of who holds what licenses (e.g., Does the company hold them internally or does a partner hold some?). The more licenses you hold inside, the more audits you will face. Audits take time and resources to manage, so that is something to think about, too.

Pim:

OK, another question has come in from the audience. If you centralize your distribution—and of course, you have to serialize your product—do you still need to register with local serialization bodies if you’re doing centralized distribution?

Ronald:

Yes, in every country where you will sell medicines in Europe, you need to work with the national medicines verification organizations (NMVOs). Some of the countries in Europe will allow almost a free ride, waiving fees for one-product companies but in general, you’ll have to contract separately with every member state where you sell product and pay both a one-off onboarding fee and annual recurring fees.

Joop:

One exception is if you have an ATMP or cell therapy product, those are excluded from serialization. But, that’s a rarer case.

Pim:

While we are on the topic of cell therapy, Joop, how would you tackle the design and implementation of the supply chain for ATMPs, which can be very different from other biotech products?

Joop:

Some ATMPs are not that different. Some cell therapies are very similar to more standard, traditional biotech products. However, some can be very different with regards to storage and processing temperatures, turnaround times, and more. This is especially true with personalized autologous cell therapy products.


So, you have to deal with these differences and guarantee the chain of custody with ATMPs. It’s best to start early. It’s also very much evolving, as the EMA is figuring out how to deal with it. As a result, the design process is very much a conversation with the authorities. That’s how you need to deal with it: engage openly with the authorities to work it out together.

Pim:

Joop, can you summarize some of the common mistakes companies make when entering the EU?

Joop:

I think we’ve covered many of them. But to summarize, some of the common mistakes are:

• Failing to have the basics in place in time

• Not establishing a solid team that prioritizes the EU

• Failing to get the expertise you need in-house or on board: You need people in Europe who know the local landscapes, and the differences between countries. You can initially do a lot from the US, but as the launch draws closer, you really need local expertise in various functions.

Pim:

Christian, if someone is in the middle of all this, what would you recommend from a team perspective?

Christian:

I think this is sometimes underestimated. You need to create a team spirit. Normally, in the beginning, you have a small team and you rely heavily on outside help. Go to visit your consultants/partners, get to know them and build trust. Don’t just have your business meetings with them, but go to lunch or dinner and see them a little bit outside of the work environment. Do this with your internal and external people.

Also, celebrate successes and milestones. This helps to motivate people. If you don’t celebrate your progress, then people can begin to lose enthusiasm and slip into a reactive mode. Overall, it’s very important to work to build that team spirit.

Pim:

Alright thanks, Christian. I think this will conclude the webinar. I would like to thank the panelists for their insights today. I would also like to thank all of the audience members for attending today and for submitting your questions. If you have any other questions, then please reach out to AIM. We are here to help!


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