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22nd APIC/CEFIC European Conference on
a sector group of
ACTIVEPHARMACEUTICALINGREDIENTS Prague, Czech Republic
23 – 25 October 2019
GMP Conference 23 - 24 October 2019
Europe‘s leadingAPI Conference
Regulatory Affairs Conference 24 - 25 October 2019
Industry Speakers:
Hélène BrugueraEDQM, France
Andrei Spinei CatalinEMA, United Kingdom
Ee-Sunn (Joanne) ChiaFDA, USA
Gabriel Ramos FerronattoANVISA, Brazil
Katsuaki UraMHLW, Japan
Bastiaan VenhuisRIVM, The Netherlands
Marieke van DalenAspen Oss B.V., The Netherlands
Ilaria DuoSiegfried Evionnaz SA, Switzerland
Jacky van GompelJanssen Pharmaceutica, Belgium
Daniella van GauwbergenJanssen Pharmaceutica, Belgium
Charles GibbonsAbbvie, Ireland
Carlos Herrero SanchezCentrient Pharmaceuticals, The Netherlands
Patty IJzermansAspen Oss B.V., The Netherlands
Sabina JurcaSandoz, Slovenia
Ulrich KisselChairman of the European QP Association
Beate MillerDSM Nutritional Products, Switzerland
Dirk OverroedderJanssen, Switzerland
Georg StrasserJanssen, Switzerland
Florent TrouilletSiegfried, Switzerland
Dieter VanderlindenAji Bio-Pharma Services, Belgium
Francois VandeweyerVDWcGMP Consultancy, Belgium
Authority Speakers:
22nd APIC/CEFIC European Conference on Active Pharmaceutical Ingredients
GMP Conference - Wednesday, 23 October 2019
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 EMA’s current ac-tivities in 2019 followed by a presentation about non sterile APIs used in sterile drug products. The following lectures are dedicated to the Supply chain security for APIs, Anti-counterfeiting activities in Europe, relevant aspects of risk based assessment of indirect materials and qualification of
suppliers and how to deal with avoidable and unavoidable particles in APIs.
In the Joint GMP and the Regulatory Affairs part of the conference you will get to know about FDA’s current practice of DMF assessment, the consequences of Brexit for APIs, how to prepare pre-approval inspections and an update on Ph.Eur. and CEP procedures.
The specific GMP and Regulatory Affairs topics to be discussed in the Par-allel Sessions will relate to Data Integrity risk assessments, practical experiences with API filings in Emerging Countries, biological extraction products, regulatory hurdles and opportunities, feedback on the 2nd revision of ICH M7 Q&A and GMPs for manufacture of clinical trial material from a CMO’s perspective.
The Parallel Sessions are no workshops. They are practically oriented and supposed to be highly interactive.
Programme
Quality Risk Management – Requirements and implementation at manufacturing levelAndrei Spinei Catalin, EMA, United Kingdom
� Implementation of ICH Q9 and QRM by regulators and industry since 2005
� What are the issues with implementation? � Lessons learnt from the recent N-Nitrosamine impurities
contamination cases
Supply chain security for APIsDaniella van Gauwbergen, Janssen Pharmaceutica, Belgium
� Complexity of API manufacturing and distribution supply chains
� APIC guidance documents on how to manage risks in API distribution chains
� Quality agreements and management of deviations within distribution processes
� Risk based approaches for temperature conditions during distribution
Non sterile APIs used in sterile drug products – industry best practiceFrancois Vandeweyer, VDWcGMP Consultancy, Belgium
� General Overview / industry situation � Guidelines/Expectations � Building Microbiological Quality into low bio-burden APIs � Challenges in assuring Microbiological Quality into low
bio-burden API’s � Control strategies for:
• Facility design• Facility operations• Environmental monitoring• Contamination risk reduction
� Conclusion
Minimizing Public Health Risks posed by Falsified MedicinesBastiaan Venhuis, National Institute for Public Health and the Environment (RIVM), The Netherlands
� Activities in Europe (CMED) � Challenges in the supply chain � The consumers’ perspective
Avoidable and Unavoidable Particles in APIDirk Overroedder, Janssen, Switzerland
� Expectations, Guidelines, Facts & Figures � Proactive Prevention vs. Mitigation � Control & Improvement Strategies
Risk based assessment of indirect materials and qualification suppliersGeorg Strasser, Janssen, Switzerland
� Regulatory requirements/expectations � Composition of a matrix of approved IM suppliers � Way forward to a risk based classification of IM � Process to qualify IM and suppliers based on the risk
categorization � Process to monitor IM and suppliers � Attention points at implementation (impact and resources)
22nd APIC/CEFIC European Conference on Active Pharmaceutical Ingredients
Programme
Social EventWednesday, 23 October 2019
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 Prague and invite all participants and speakers to an entertaining
evening outside the hotel followed by a dinner.
Parallel Sessions - Thursday, 24 October 2019Please choose 2 out of 6 parallel sessions (one choice in Session Part I and one in Session Part II):
Coffee Break
Lunch Break
SESS
ION
PA
RT I
SESS
ION
PA
RT II
Session 1:Data integrity – practical examples on how to perform gap analysis and risk assessments
Dieter Vanderlinden, Aji Bio-Pharma Services, BelgiumCharles Gibbons, Abbvie, Ireland
� How to approach data integrity using APIC guide’s methodology – Identify, assess and remediate any potential data
� Integrity risks within your company � Discussion of some practical examples in a
manufacturing and lab environment
Session 2:APIC‘s Experience with Supporting Documenta-tion for API filings in Emerging Countries
Ilaria Duo, Siegfried Evionnaz SA, SwitzerlandBeate Miller, DSM Nutritional Products, Switzerland
� Emerging Countries Interest Group - What is it? What do we do?
� Experience when using an Active Substance Master File (ASMF) / Drug Master File (DMF)
� Experience when using a Certificate of the European Pharmacopoeia (CEP)
Session 3:Biological extraction products
Patty IJzermans, Aspen Oss, The Netherlands
� Specifics of extraction products � Applicability of guidelines
Session 4:Regulatory hurdles and opportunities
Marieke van Dalen, Aspen Oss, The Netherlands
� APIC tips and trics for dealing with regulatory issues
Session 5:Feedback on the second revision of the Q&A sec-tion of ICH M7 guideline
Jacky van Gompel, Janssen Pharmaceutica, Belgium
� New compound list and ADE’s � Quality related Q&A’s � Safety related Q&A’s
Session 6:GMPs for Manufacture of clinical trial material – a CMO’s perspective
Florent Trouillet, Siegfried (Evionnaz), Switzerland
� Regulatory requirements vs. customer expectations
� Focus on development vs validation readiness (risk management, documentation, cleaning, changes)
� Cases studies on challenges in daily operations
APIC Best Practice Guides
APIC developed a number of Best Practice Guides on GMP and Regulatory Affairs, e.g.
� New: Data Integrity Best Practices Guide for APIs, version 1, March 2019
� Revision: Guideline Technical Change Control revised, Nov 2018 � Revision: How to do - Interpretation of ICH Q7 document, Nov 2018 � New: Auditing Registered Starting Material manufacturers, 2018
Annex 1 - Aide Mémoire Learn about the implementation of these Guidelines at the 22nd Conference on GMP for APIs or at the Pre-Conference.
You will receive a free copy of all APIC Guidelines!
Do impacts generated by Brexit on APIs concern the QP? Ulrich Kissel, Chairman of the European QP Association
� What does change for APIs after Brexit? � importation from UK to EU � importation by UK from EU � any change to handle APIs sourced from China, India, US,
other sources? � written confirmation and Brexit � some flashlight on EU GMP Part II, ICH Q7 and Brexit
FDA‘s current practice for DMF assessmentEe-Sunn (Joanne) Chia, FDA, USA
� Division of Lifecycle API : role and responsibilities � DMF assessments: how to improve first time right � GDUFA 2 metrics: some key figures, plans for improvement
Joint GMP and Regulatory Affairs Day - Thursday, 24 October 2019
Regulatory Affairs Conference - Friday, 25 October 2019
Update on ANVISA activitiesGabriel Ramos Ferronatto, ANVISA, Brazil
� Regulatory activities � Inspection activities � International cooperation
Regulatory update in Japan – for addressing innovative technologyKatsuaki Ura, MHLW, Japan
� Revision of the Pharmaceuticals and Medical Devices Act � Addressing novel manufacturing concept/technology � Internatinal collaboration for innvovation
ObjectivesAfter several Regulatory topics will have been presented during the second conference day, the RA conference will highlight key aspects of registration
procedures in China, Japan and Brazil as well as aspects of world wide API assessment.
Registration in ChinaSabina Jurca, Sandoz, Slovenia
� Current China regulatory landscape � API registration requirements and procedures � Recent experience of API industry with China registrations
The Ph. Eur and CEP procedure in 2019Hélène Bruguera, EDQM France
� The Ph. Eur 10th edition and its priorities for the future � Links between the Ph. Eur and CEPs � Update on CEP guidelines and procedures � Improving the use of CEPs to support in marketing
applications � impact of the Brexit on EDQM activities
Important InformationYou will receive a USB memo stick when you register in Prague. Note: there will be no print-outs available during the conference.
API assessment world wideMarieke van Dalen, Aspen Oss, The Netherlands
� What are the similarities � Differences in format and content � Change control procedures
Pre-Approval Inspections: How to prepare best practiceCarlos Herrero Sanchez, Centrient Pharmaceuticals, The Netherlands
� Is a PAI Inspection any different to a routine Inspection? � Who can inspect - Inspectorates and/or others? � Preparing and verifying file compliance prior to submission � Getting site ready for both GMP and regulatory compli-
ance inspection � Who should be in attendance for the Inspection from the
MAH
The Venue in PragueInterContinental Praha
An enchanting landmark hotel in the very centre of this magical city, just minutes from top tourist sights and designer shops as well as bustling cafes and restaurants. Features include:
� Free WiFi � Free health club and spa � Tea/coffee maker in all rooms � Gourmet cuisine in rooftop restaurant Zlatá Praha
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 Luft-hansa German Airlines offers a comprehensive global route network link-ing 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:
� Tom Buggy, Royal DSM, The Netherlands � José Lluis Caparros, Centrient Pharmaceuticals, The Netherlands � Landry Le Chevanton, DSM Nutritional Products Europe, 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, United Kingdom � Francois Vandeweyer, VDWcGMP Consultancy, Belgium � Hilde Vanneste, Janssen Pharmaceutica, Belgium � Vicky Waddington, Mallinckrodt Pharmaceuticals, Ireland � 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 Position Papers e.g. on API Starting Material, Post-approval Changes and many more.
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How to audit registered Starting Materials manufacturers
a pre-Conference Session on 22 October 2019
This pre-Conference Session ideally complements the subsequent 22nd APIC/CEFIC Conference on Active Pharmaceutical Ingredients.If you register both for the pre-Conference Session „How to audit registered Starting Materi-
als manufacturers“ and the 22nd APIC/CEFIC Conference, you will benefit from a special rate
of 890 € (instead of 990 €) for the pre-Conference Session!
22nd APIC/CEFIC European Conference on Active Pharmaceutical Ingredients23 - 25 October 2019, Prague, Czech RepublicI want to take part in
� GMP Part (23-24 October 2019) � Regulatory Affairs Part (24-25 October 2019) � All three conference days (23-25 October 2019)
Please choose 2 out of 6 parallel sessions (one choice in Session I and one in Session II): Parallel Sessions I Session 1: Data integrity – practical examples on how to perform gap analysis and risk assessments Session 2: APIC’s Experience with Supporting Documentation for API filings in Emerging Countries Session 3: Biological extraction products
Parallel Sessions II Session 4: Regulatory hurdles and opportunities Session 5: Feedback on the second revision of the Q&A section of ICH M7 guideline Session 6: GMPs for Manufacture of clinical trial material – a CMO’s perspective
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, 22 October 2019, 19.00 – 20.00 h or Wednesday, 23 October 2019, 09.00 h - 10.00 hRegulatory Affairs Part: Thursday, 24 October 2019, 8.30 - 9.00 h
Conference DateWednesday, 23 October 2019, 10.00 h – 17.20 hThursday, 24 October 2019, 09.00 h – 17.25 hFriday, 25 October 2019, 09.00 h – 13.00 h
VenueInterContinental PrahaPařížská 30110 00 Praha 1Czech RepublicPhone: +420 296 631 111Fax: +420 224 811 216Email: [email protected]
Fees (per delegate plus VAT)Book the GMP Part (23-24 October) or the Regulatory Affairs Part (24-25 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 [email protected]
For question regarding content: Dr Gerhard Becker (Operations Director) at + 49 (0) 6221/84 44 65, or at [email protected]
For questions regarding reservation, hotel, organisation etc.:Ms Marion Grimm (Organisation Manager) at + 49 (0)6221/84 44 18, or at [email protected]
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 “How to audit registered Starting Materials Manufacturers “ at the special rate of 890 € plus VAT.
Reservation Form:+ 49 6221 84 44 34
e-mail:[email protected]
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.
