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PERSONAL DATA Anne Sørensen (131268)

Elsdyrvej 18

4623 Lille Skensved

( 24 41 59 19

e-mail: as@pharmac.dk

PROFESSIONEL EXPERIENCE

2014

2010

2007

Oct.

Apr.

Feb.

Senior GxP Consultant, Pharmac ApS

Head of Production, Region Sjælland Sygehusapoteket (Region Zealand, Hospital Pharmacy)

Director, Quality Assurance. Qualified Person. Egalet a/s

2003 Jan. Director of Analysis and QA/QC and Qualified Person. Egalet a/s

2002 Feb. Manager of Analysis and QA/QC and Qualified Person. Egalet a/s

1997 Jan. Production Manager Non-sterile liquids at Leo Pharma.

1995 Jan. Head of section Tablet Production at Leo Pharma

1994 Oct. Pharmacist in Finished Product Packaging at Leo Pharma

1993 - 1994 Pharmacy Technician at Nærum Pharmacy

SENIOR GXP CONSULTANT, PHARMAC, MAIN EXPERIENCE 2019 Present Faglig ansvarlig farmaceut, private hospital pharmacy incl. FMT production in GMP faclilies

2019 Present Qualified Person/Quality Manager, certification of unlicensed medicine/investigational medicine

2018 2018 Qualified Person, sterile vial manufacturing, allergy immunotheraphy (7 months)

2017 Present Qualified Person, products manufactured outside Europe released in DK for the Nordic marked

2015 2016 Qualified Person, non-sterile pharmaceutical manufacturing

2014 - 2019 Head of Quality Assurance/Quality Control, Cosmetics

In the period from 2014 to present I have held more than 40 audits of API and finished goods manufacturers including audits

of warehouses for API and finished goods besides several internal audits in Denmark and in Europe.

Additionally, I have done project based consultancy work within Quality Assurance for several pharmaceutical and cosmetic

companies including assistance in setting up a cannabis manufacturing facility.

COURSES / TRAINING 2020

2019

Feb.

Nov.

Cannabislovgivningen, Pharmakon a/s, Denmark

14th QP Forum, QP Association, München, Germany

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2019

2018

2018

2017

2017

2017

2017

2017

2016

2016

2015

2015

2015

2014

2014

2013

2013

2013

2012

2012

2011

2011

2010

2009

2009

2009

2009

2008

2008

Nov.

Nov.

Mar.

Nov.

Sep.

Jul.

Jun.

May

Sep.

May

Dec.

Nov.

Feb.

Dec.

Nov.

Nov.

Jun.

Jan.

Nov.

Okt.

Nov.

Mar.

Mar.

Nov.

May

Feb.

Jan.

Nov.

Sep.

Cannabidiol i kosmetik, Kosmetik- og hygiejnebrancen, Denmark GMP latest news, Pharmakon a/s, Denmark

Introduction to ISO 13485 Medical Device, Denmark

GMP latest news, Pharmakon a/s, Denmark

Good Distribution Practice, Pharmakon a/s, Denmark

How to write an ASMF, Pharmalex Denmark

GMP Compliance Auditing, Key2Compliance, Copenhagen

Audit Trail, Stage One Computing, IFF, Symbion Denmark

Process validation, Pharmakon a/s, Denmark

Cleaning validation strategy, techniques and regulations, Key2Compliance, Copenhagen

Mettler Toledo GWP and minimumweighing training, Denmark

GMP latest news, Pharmakon a/s, Denmark

GMP in the laboratory, Mads Friis Sørensen, Pharmac at Riemann A/S Hillerød

ICH Q7 Compliance for APIs (including special session on APIs Manufactured by Cell

Culture/Fermentation, ECA, Berlin

GMP latest news, Pharmakon a/s, Denmark

GMP latest news, Pharmakon a/s, Denmark

Contamination Control in clean rooms, GMP requirements and industrial practice (EU and FDA),

Key2Compliance, Copenhagen

LEAN and Strategy Map, Lars Dyrby Johansen, Management Consultant - Valcon

Strategic communication and Culture development, Region Zealand, Denmark

Introduction to Quality Risk Management jf. EU GMP Vol IV Part III, Hjorth Kvalitetsudvikling, Denmark

Manufacturing and Validation of Sterile Drugs, Pharmakon a/s, Denmark

Support for the process of change - a leadership development for managers in Region Zealand

(3x2 days)

Hands on Risk Assesment with Case Studies. IFF. Symbion Denmark

Workshop on An Incremental Approach to GMP from early to late phase Product Development

including Responsibility for Release of Clinical Batches. IFF. Symbion Denmark

Workshop CAPA, IFF and Karen Ginsbury, Symbion Denmark

Change Control Management, IFF and Karen Ginsbury, Symbion Denmark

GMP – trends, IFF and David Begg Associates, Symbion Denmark

Recommendations on how to apply ICH Q8/Q9/Q10 during audits, Key2Compliance, Copenhagen

Validation and Qualification Compliance Requirements, Key2Compliance, Copenhagen

2007 Nov. Management of clinical trials - GMP meets GCP, ECA, Berlin

2007 Oct. ICH Quality Guidelines Q1-10 an overview, Pharmakon a/s, Denmark

2007 May Practical Approaches to Global GMP for Investigational Medicinal Products, Key2Compliance,

Stockholm, Sweden

2005 May Role of the European Qualified Person, IIR, London

2005 Mar. The Mechanics of Preparing INDS & NDAS & FDA Regulations, The center for Professionel

Advancement, Amsterdam

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SCIENTIFIC CONFERENCES/WORKSHOPS 2014

2012

2009

2009

2009

2009

2008

2006

Mar.

Mar.

May

May

Feb.

Jan.

May

Apr.

EAHP Congress (European Association Hospital Pharmacists), Barcelona

EAHP Congress (European Association Hospital Pharmacists), Milan

Speaker presentation ISPE Baseline Guideline Vol. 12 and FDA Process Validation, IFF Copenhagen

Speaker presentation ASTM E2500 standard, Risk based Verification, IFF Copenhagen

Workshop Change Control/Management, IFF Copenhagen

Workshop GMP-trends, IFF Copenhagen

Workshop CAPA, IFF Copenhagen

Integrating Development and Manufacturing, ISPE Copenhagen conference

2004 Oct. 4th Annual Life Science Symposium, Process Analytical Technology, Copenhagen

2003 Dec. Information Day, Danish Medicine Agency

2003 Nov. ISPE Nordic Annual Meeting, Copenhagen

2002 Sep. Inspectorate Information Day, IMB, Ireland