21st APIC/CEFIC European Conference on

a sector group of

ACTIVEPHARMACEUTICALINGREDIENTS Budapest, Hungary

24 – 26 October 2018

GMP Conference 24 - 25 October 2018

Regulatory Affairs Conference 25 - 26 October 2018

Industry Speakers:

Hélène BrugueraEDQM France

Gabriel Ramos FerronattoANVISA, Brazil

Maria FilanciaEMA, United Kingdom

Rainer GniblEU-GMP Inspector, Germany

Amirthini Rajkumar Health Canada

Landry Le ChevantonDSM, Switzerland

David Cockburnformerly European Medicines Agency (EMA)

Marieke van DalenAspen Oss B.V., The Netherlands

Iliaria DuoSiegfried Evionnaz SA

Joerg GampferHovione, Portugal

Markus GoeseF. Hoffmann-La Roche, Switzerland

Oksana GolychevaJanssen Pharmaceutica, USA

René van HerpenAspen Oss B.V., The Netherlands

Martijn KlopSynthon, The Netherlands

Arjen te NijenhuisJanssen Pharmaceutica, Belgium

Danny de ScheemaeckerJanssen Pharmaceutica, Belgium

Michael TowardJohnson Matthey MacFarlan Smith, United Kingdom

Francois VandeweyerJanssen Pharmaceutica, Belgium

Guy VillaxHovione, Portugal

David ZhouChina Chamber of Commerce for Import and Export of Medicines and Health Products (CCCMHPIE), China

Authority Speakers:

Europe‘s leadingAPI Conference

21st APIC/CEFIC European Conference on Active Pharmaceutical Ingredients

GMP Conference - Wednesday, 24 October 2018

Objectives of the ConferenceThe APIC/CEFIC Conference on Active Pharmaceutical Ingredients is Eu-rope’s leading event. Many major stakeholders from Authorities and the Industry are each year joining this Conference. Speakers from EMA, EDQM, National Authorities, from Industry and Industry Associations will discuss the latest developments in the field of GMP and Regulatory Compliance.

The GMP Conference, of which the final part is a Joint GMP & RA session, provides updates from recent authorities’ initiatives, activities and inter-pretations related to GMP compliance of API manufacturing. Hear from industry speakers their approaches and best practices on compliance re-lated to the various existing and emerging aspects of API GMP.

The conference will be opened by a presentation about FDA latest initia-tives in 2018 with special focus on the EU-US-MRA followed by a presenta-tion about current findings from EU-GMP inspections at EU & Asian API manufacturers. The following lectures are dedicated to the Brexit and the consequences for the API industry, the latest development of the EU-US-MRA, the current regulatory landscape in Canada and Data Integrity as-pects in the API production area.

In the Joint GMP and the Regulatory Affairs part of the conference you will get to know what authorities can do about drug shortages, the latest re-quirements for API registrations in Eastern Europe an update on ANVISA’s international cooperation and on EDQM’s activities and initiatives. Fur-thermore you will hear presentations about the EU ASMF assessment worksharing, Industry point of view of the ICH Q12 guideline and recent developments regarding API regulations in China. The conference will be rounded off by a presentation about the way towards global harmoniza-tion of regulatory requirements.

The specific GMP and Regulatory Affairs topics to be discussed in the Par-allel Sessions will relate to practical experiences with API filings in Emerg-ing Countries, risk based audits of regulatory starting materials, statistical approaches to process validation, ICH Q3D consequences for APIs, Drug Substance control strategies and aspects of fraud in the supply chain of

APIs and raw materials.

The Parallel Sessions are no workshops. They are practically oriented and supposed to be highly interactive.

FDA latest initiatives in 2018FDA speaker

Current findings from EU-GMP inspections at EU- & Asian API manufacturersRainer Gnibl, EU GMP Inspector, Bavarian Government, Germany

� Which areas supposed to get critical � Major & critical deficiencies found

� Difference between asian- & EU-companies?

Brexit: consequences for the API industryArjen te Nijenhuis, Janssen Pharmaceutica, Belgium

Programme

EU-US MRAMaria Filancia , Committees and Inspections Department, EMA, United Kingdom

� International collaboration on GMP inspections � EU-US MRA scope and applicability � EU-US MRA timelines and milestones � EU-US MRA implementation � Next steps

Current regulatory landscape in CanadaAmirthini Rajkumar, Health Products and Food Branch, Health Canada

� Use of CEPs as supporting information in drug submission � Use of foreign reviews in Canada � Recently published quality guidance documents � Current developments

Data Integrity in API manufacturingDanny de Scheemaecker, Janssen Pharmaceutica, Belgium

� A practical risk-based guidance on the implementation of data integrity measures compliant with current regulatory guidances

� Explanation of an overall DI assessment approach, starting from business processes and data mapping until final risk management.

� How to do in practice (some examples)

21st APIC/CEFIC European Conference on Active Pharmaceutical Ingredients

Programme

Social EventWednesday, 24 October 2018

The social event has become a tradition and was well appreciated during the past conferences in well-known places. We will continue this tradition in Budapest and invite all participants and speakers to an entertaining

evening outside the hotel followed by a dinner.

Parallel Sessions - Thursday, 25 October 2018Please choose 2 out of 6 parallel sessions (one choice in Session Part I and one in Session Part II):

Session 1:

APIC‘s experience with suppor-ting documentation for API filings in Emerging Countries

Michael Toward, Johnson Matthey MacFarlan Smith, United KingdomIliaria Duo, Siegfried Evionnaz SA

� Emerging Countries Interest Group – What is it and what do we do?

� Supporting documentation required when

using a CEP.

� Supporting documentation required when

using a DMF.

Session 2:

Risk-based use of audits in the life cycle approach of a regulatory starting material – industry perspective

Francois Vandeweyer, Janssen Pharmaceutica, Belgium

� What is needed to evaluate an RSM?

� What part does an audit play in the evaluation

and lifecycle approach of the RSM?

� What are the required standards needed for

manufacture of a RSM and hence what and

how you audit these requirements?

� Use of Q9 risk assessments in the maintenance

of the RSM life cycle

Session 3:

Statistical approach to process validation

René van Herpen, Aspen Oss B.V., The Netherlands

� Pros and cons of current (draft) guidance

� EMA Reflection paper on statistical

methodology, FDA guidance and Q5E

� Consequences for industry

Session 4:

ICH Q3D consequences for APIs

Landry Le Chevanton, DSM, Switzerland

� Status of implementation of ICH Q3D

� Update on ICH Q3D Working Group

Session 5:

Drug Substance Control Strategy

Joerg Gampfer, Hovione, Portugal

� Elements of a Control Strategy

� Identification of Criticality and designing

Controls

� Continuous Improvement – A lifecycle

approach to Control Strategies

Session 6:

Fraud in the supply chain

Guy Villax, Hovione, Portugal

� Case studies

� When things go wrong, what matters is how

you deal with it

� Quality culture versus compliance

Coffee Break

Lunch Break

SESS

ION

PA

RT I

SESS

ION

PA

RT II

API registrations in Eastern EuropeOksana Golycheva, Janssen Pharmaceutica, USA

� What does current Russian/Eurasian union API legislation look like?

� How is the Russian Health Authority organised? � API legislation process for initial submissions and post

approval changes � What is role and impact of inspections on the registration

process?

Global harmonization: Utopia?Marieke van Dalen, Global CMC RA/CRS, Aspen Oss B.V., The Netherlands

� International harmonization programs � Current status � Way forward

Joint GMP and Regulatory Affairs Day - Thursday, 25 October 2018

Regulatory Affairs Conference - Friday, 26 October 2018

Important InformationYou will receive a USB memo stick when you register in Budapest.Note: there will be no print-outs available during the conference.

What can authorities do about drug shortages?David Cockburn, formerly European Medicines Agency (EMA)

� Who is responsible for medicines supply? � What causes medicines shortages? � Which causes can be influenced by regulatory authorities? � Examples of practical measures

� Is there a need for industry guidance?

Update on EDQM activitiesHélène Bruguera, EDQM France

� Preparing the 10th edition of Ph. Eur – hot topics � Update on the CEP procedure � Changes to revisions of CEPs � Update on EDQM inspections

Update on ANVISA activitiesGabriel Ramos Ferronatto, ANVISA, Brazil

ICH Q12 – Industry point of viewMarkus Goese, F. Hoffmann-La Roche, Switzerland

� Established conditions

- What does it mean? - How to define? - Expected impact on variations

� PACMP – Post Approval Change Management Protocols - Purpose - Why and how a PACMP can help?

� PLCM – Product Life Cycle Management: Purpose � Why and how it should be included in the CTD?

The changes in the regulatory procedures in China: expectations from the Health authori-ties with respect to API informationDavid Zhou, China Chamber of Commerce for Import and Export

of Medicines and Health Products (CCCMHPIE), China

ObjectivesAfter several Regulatory topics will have been presented during the second conference day, the RA conference will highlight key aspects of the EU

ASMF assessment worksharing, industry’s perspective on ICH Q12, the latest Chinese API regulations and International harmonization programs.

EU ASMFs: worksharing and eCTDMartijn Klop, Synthon, The Netherlands

� The EU ASMF assessment worksharing

� eCTD submissions in the EU

The Venue in BudapestCorinthia Hotel Budapest

First opened in 1896 as the Grand Hotel Royal, Corinthia Hotel Budapest

remains among the grandest in the city. Meticulously renovated, the

hotel‘s rich history blends seamlessly with state-of-the-art features, such

as an original 19th century spa, elegant eateries, two bars and the city‘s

largest hotel conference facilities. Features include:

� Hungarian, English, German, French, Spanish and Italian-speaking staff

� Complimentary Wi-Fi throughout the hotel

� Business Centre

� Parking and car wash service

Lufthansa is Mobility Partner forall Concept Heidelberg Events As a Concept Heidelberg course or conference attendee, you will receive

up to 20% discounted travel fares (according to availability).

And as Lufthansa German Airlines offers a comprehensive global route network linking major cities around the world you will most likely be able

to benefit from these special prices and conditions.

And this is how it works: Once you registered for a course or conference you will receive a link together with your registration confirmation.

Opening that link will take you to the Mobility Partner Program website where you can enter a code in the “Access to Event Booking” area you will also receive. This will take you into an online booking platform* that will automatically calculate the discount offered or provide you with an even

better offer if another promotional fare is available.

We look forward to welcoming you at one of our next events – and we

already wish you a pleasant flight!

*Please note: You may have to enable pop-ups on the Mobility Partner Program website – oth-erwise the booking platform window will not open.

Steering CommitteeWe would like to express our sincere gratitude to the members of the steering committee for developing the conference:

� Jose Lluis Caparros, DSM Sinochem, Switzerland � Landry Le Chevanton DSM, Switzerland � Marieke van Dalen, Aspen Oss, The Netherlands � Rainer Fendt, BASF, Germany � Nessa Fennelly, IBEC, Ireland � Pieter van der Hoeven, CEFIC, Belgium � Graca Mata, Hovione, Portugal � Matt Moran, IBEC, Ireland � Luisa Paulo, Hovione, Portugal � Anthony Storey, Pfizer, UK � Vicky Waddington, United Kingdom � Hilde Vanneste, Janssen Pharmaceutica, Belgium � Gerhard Becker, CONCEPT Heidelberg, Germany

� Oliver Schmidt, CONCEPT Heidelberg, Germany

About APICAPIC‘s membership consists of companies from different pharmaceutical industry sectors, all involved in the manufacture of APIs. This provides an ideal basis for developing and communicating a balanced, holistic view on API-related regulations and guidelines. APIC’s focus is on worldwide Quality, Good Manufacturing Practice (GMP) and Regulatory matters relat-ing to APIs and Intermediates. Through the years APIC has developed into a high-profile industry association with an excellent, worldwide reputa-

tion.

APIC‘s Best Practice Documents

APIC has developed many Best Practice Documents such as the ICH Q7 How-to-do Guide, the APIC Audit Programme, and Po-sition Papers e.g. on API Starting Material, Post-approval Changes and many more.

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ICH Q7 How to doHot Topics from the revised APIC guidance

a pre-Conference Session on 23 October 2018

This pre-Conference Session ideally complements the subsequent 21st APIC/CEFIC Conference on Active Pharmaceutical Ingredients.If you register both for the pre-Conference Session „ICH Q7 How to do - Hot Topics from the

revised APIC guidance“ and the 21st APIC/CEFIC Conference, you will benefit from a special

rate of 790 € (instead of 990 €) for the pre-Conference Session!

21st APIC/CEFIC European Conference on Active Pharmaceutical Ingredients24 - 26 October 2018, Budapest, HungaryI want to take part in

� GMP Part (24-25 October 2018) � Regulatory Affairs Part (25-26 October 2018) � All three conference days (24-26 October 2018)

Please choose 2 out of 6 parallel sessions (one choice in Session I and one in Session II): Parallel Sessions I

Session 1: APIC‘s experience with supporting documentation for API filings in Emerging Countries Session 2: Risk based use of audits in the life cycle approach of a regulatory starting material

Session 3: Statistical approach to process validation Parallel Sessions II Session 4: ICH Q3D consequences for APIs Session 5: Drug substance control strategy Session 6: Fraud in the supply chains

Mr Ms Title _______

First name, surname

Company o APIC Member o ECA Member o Inspectorate

Department

Important: Please indicate your company’s VAT ID Number P.O. Number if applicable

Street / P.O. Box

City Zip Code Country

Phone / Fax

E-mail (please fill in)

���

���

RegistrationTuesday, 23 October 2018, 19.00 – 20.00 h or Wednesday, 24 October 2018, 09.00 h - 10.00 hRegulatory Affairs Part: Thursday, 25 October 2018, 8.30 - 9.00 h

Conference DateWednesday, 24 October 2018, 10.00 h – 17.20 hThursday, 25 October 2018, 09.00 h – 17.25 hFriday, 26 October 2018, 09.00 h – 13.00 h

VenueCorinthia Hotel Budapest Erzsébet körút 43-49Budapest H-1073 HUNGARY Phone +36 1 479 4000 Fax +36 1 479 4333budapest@corinthia.com

Fees (per delegate plus VAT)Book the GMP Part (24-25 October) or the Regulatory Affairs Part (25-26 October) separately for the price of € 1,680.- each.

Or book all three conference days for the special price of € 1,990.-.

The registration fee is payable in advance after receipt of invoice.

DiscountsAPIC Members 10 %, ECA Members 5%, Inspectorates 25 %. Please note that discounts cannot be combined!

AccommodationCONCEPT has reserved a limited number of rooms in the conference hotel. You will receive a room reservation link when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.

RegistrationVia the attached reservation form, by e-mail or by fax message. Or you register online at www.api-conference.org

Conference languageThe official conference language will be English.

Organisation and Contact CONCEPT HEIDELBERGP.O. Box 10 17 6469007 Heidelberg, GermanyPhone +49 (0) 62 21/84 44-0Fax +49 (0) 62 21/84 44 34info@concept-heidelberg.dewww.concept-heidelberg.de

For question regarding content: Dr Gerhard Becker (Operations Director) at + 49 (0) 6221/84 44 65, or at becker@concept-heidelberg.de

For questions regarding reservation, hotel, organisation etc.:Ms Marion Grimm (Organisation Manager) at + 49 (0)6221/84 44 18, or at grimm@concept-heidelberg.de

If the bill-to-address deviates from the specification to the right, please fill out here:

__________________________________

CONCEPT HEIDELBERG P.O. Box 10 17 64 Fax +49 (0) 6221/84 44 34

69007 Heidelberg Germany

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� I also register for the pre-Conference Session “ICH Q7 How to do – hot topics from the revised APIC guidance “ at the special rate of 790 € plus VAT.

Reservation Form:+ 49 6221 84 44 34

e-mail:info@concept-heidelberg.de

Internet:www.api-conference.org

General terms and conditionsIf you cannot attend the conference you have two options:1. We are happy to welcome a substitute colleague at any time.2. If you have to cancel entirely we must charge the following processing fees: Cancellation

� until 2 weeks prior to the conference 10 %, � until 1 weeks prior to the conference 50 % � within 1 week prior to the conference 100 %.

CONCEPT HEIDELBERG reserves the right to change the materials, instructors, or speakers without notice or to cancel an event. If the event must be cancelled, registrants will be notified as soon as possible and will receive a full refund of fees paid. CONCEPT HEIDELBERG will not be responsible for discount airfare penalties or other costs incurred due to a cancellation. Terms of payment: Payable without deductions within 10 days after receipt of invoice. Important: This is a binding registration and above fees are due in case of cancellation or non-appearance.

If you cannot take part, you have to inform us in writing. The cancellation fee will then be calculated according to the point of time at which we receive your message. In case you do not appear at the event without having informed us, you will have to pay the full registration fee, even if you have not made the payment yet. Only after we have received your payment, you are entitled to participate in the conference (receipt of payment will not be confirmed)! (As of January 2012).

German law shall apply. Court of jurisdiction is Heidelberg.

Privacy Policy: By registering for this event, I accept the processing of my Personal Data. Concept Heidelberg will use my data for the processing of this order, for which I hereby declare to agree that my personal data is stored and processed. Concept Heidelberg will only send me information in relation with this order or similar ones. My personal data will not be disclosed to third parties (see also the privacy policy at http://www.gmp-compliance.org/eca_privacy.html). I note that I can ask for the modification, correction or deletion of my data at any time via the contact form on this website.