2015 Training C alendar · Training Completed 2015 -TrainingCalenda r_MRA -FPD_v2_2015 -01 -27 Training has been rescheduled from a previously published calendar version

Training Completed 2015-TrainingCalendar_MRA-FPD_v2_2015-01-27 Training has been rescheduled from a previously published calendar version Please remember to book your seat with FPD by the latest 2 weeks prior to training to avoid disappointment. Booking details are in the accompanying brochures.

2015 Training Calendar

Course Title Jan Feb Mar April May June July Aug Sep Oct Nov Dec

Short Course in Pharmaceutical Regulatory Affairs for Executives [2 days]

26

22

27 23

Short Course in Pharmaceutical Regulatory Affairs for Marketing Departments [2 days]

14

6

15 7

Short Course in Pharmaceutical Regulatory Affairs for Regulatory Affairs Managers / Responsible Pharmacist (RPs) [3 days]

20

21 21 22

22 23

Short Course in Pharmaceutical Regulatory Affairs for Registration Assistants [5 days]

18

2

19 3 20 4 21 5 22 6

Short Course in Pharmaceutical Regulatory Affairs for the Senior Regulatory Affairs Pharmacist with ≥ 5 Years’ Experience [3 days]

9

10 11

Short Course in Pharmaceutical Regulatory Affairs for the Pharmacovigilance Officer [3 days]

3

4 5

2015 Training Calendar Interactive Version 27 January 2015

Foundation for Professional Development (Pty) Ltd, Registration number 2000/002641/07

Registered with the Department of Education as a Private institution of Higher Education under the Higher Education Act, 1997. Registration number: 2002/HE07/013

SHORT COURSE IN PHARMACEUTICAL

REGULATORY AFFAIRS FOR EXECUTIVES INTRODUCTION

The Pharma Industry is well established in South Africa and comprises companies who are involved in a multitude of activities, be they manufacturing, import, export, research, development, wholesaling or distribution. As for all companies, strong leadership is required to keep the company functioning at an optimum level of compliance and profitability. In healthcare this is no different, if not even more complicated. The responsibilities for compliance in a company involved in the sale of healthcare products include developing and implementing corporate strategies, managing the overall operations and managing the resources of the company in accordance with Good Practice requirements which form part of the assessment of compliance. Within the corporate structure is the Pharmaceutical Regulatory Affairs Department, with the Responsible Pharmacist, who has the mandate by law to communicate with the Regulator, i.e. the Medicines Control Council and the Medicines Regulatory Authority. This mandate covers all matters relating to the registration, regulation and control of medicines. Thus, the interaction, communication and understanding between the Executive(s) and the Responsible Pharmacist/Regulatory Affairs Department is critical for the day-to-day operations and for the strategic planning for the company.

WHO SHOULD ENROLL / ATTEND

Persons who are appointed in an executive position in a pharmaceutical company in South Africa, and who will like to / need to gain additional skills, knowledge and insight into the Pharmaceutical Regulatory Affairs field should attend. This will include the statutory and policy requirements, and the roles and responsibilities and interaction with the pharmaceutical Regulatory Affairs Department of the company and the Executives to achieve the company’s goals and mission.

COURSE OUTCOMES

At the end of the course, the course delegates will:

• Be familiar with the roles and responsibilities, and operational and strategic functions of a Regulatory Affairs Department in a Pharmaceutical Company in the local and global medicines regulatory, registration and control environment.

• Be familiar with the current statutory roles and responsibilities, functions, and operational and strategic activities of the Responsible Pharmacist in the Regulatory Affairs Department in a Pharmaceutical Company.

• Be familiar with the Regulators/Statutory Bodies etc including: - Overview of MCC and MRA structure and functions in terms of the Medicines Act, Act 101 of 1965

- Overview of the SA Pharmacy Council’s structure and functions in terms of the Pharmacy Act, Act 53 of 1974

- Advertising Standards Authority of South Africa - Consumer Protection Act (CPA Act 68/2008) - SAPC, HPCSA and other practitioners' councils - Marketing Code Authority (MCA) and Code of Marketing Practice

• Have an understanding of the various pieces of legislation, including Medicines and Related Substances Act and the Pharmacy Act and National Development Programme.

• Have a concept of the Safety, Quality and Efficacy requirements of pharmaceutical products.

• Have insight and understanding of the registration process flow and evaluation procedure.

• Know the different types of Applications and the types of Medicines.

• Basic understanding of the current medicine registration dossier fundamentals viz.: the ZA-CTD format, it’s modules, sections and granularity.

• Be aware of the Lifecycle Management of a dossier.

• Know types of fees payable, why and to whom.

• Understand the rate limiting aspects to dossier submission – understand “critical shortcomings”.

• Be aware of Good Manufacturing Practice – good, basic understanding of responsibilities tied up in Licensing (in terms of Act 101/1965, Act 53 / 1974)

• Be aware of GMP Inspections / Audits by Inspectorate/Law Enforcement – what is expected.


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• Be aware of the importance of the product labelling, viz: the PI, PIL and labelling.

• Be aware of the importance of Vendor/ Supplier Inspections and Audits.

• Know and understand Systems and Workflows within a Regulatory Affairs Department.

• Be aware of and understand the need for Dossier Management Tools, and Electronic File Management – including of availability of document management software to meet local and international electronic requirements.

• Understand the Product Dossier Lifecycle Management, Maintenance and Amendments – very high level.

• Understand what Pharmacovigilance is - Adverse events/Adverse Drug Reactions - the roles and responsibilities of Regulatory Affairs Pharmacovigilance Officer, in reporting.

• Be aware of Perverse Incentives.

• Have a good understanding of Complaints Management - Quality matters – High level.

• Have a good understanding for the requirements for Contracts as per the GMP and PIC/s requirements, as well as the GRP, GCP, GWP and GLP aspects, with 3

rd party contractors etc.

• Have a good understanding of Manufacturing and Change Control Management – very high level – and its effect on the activities and output of the Regulatory Affairs Department.

• Understand what is required in an Annual (Quality) Product Review for each registered and marketed product.

• Know and understand the Transparent Pricing System and Single Exit Price.

• Know and understand the Code of Marketing Practice.

• Pharmacoeconomics.

• Have undergone an interactive discussion sessions, providing networking and problem – solving and better insight into the Regulatory Affairs in South Africa.

CERTIFICATION To qualify for the certificate of attendance for this short course, participants should fully attend course. The practical scenarios/sessions must be completed to the satisfaction of the Facilitator.

COURSE FEE, DATE, VENUE AND PAYMENT

R 6 023.76 (Inclusive of all VAT and taxes where applicable). 2 Day Course Attendees are responsible for paying the full course fee before commencement thereof. DATE VENUE FINAL REGISTRATION

DATE

26 – 27 March 2015 TBC 19 March 2015

22 – 23 October 2015 TBC 15 October 2015

REGISTRATION

CHANTAL ODENDAAL / ILANA SWART Tel: 012 816 9103/9254 Fax: 086 567 2243 Email: [email protected] [email protected] Address: P.O. Box 75324, Lynnwood Ridge, 0040 Website: www.foundation.co.za


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SHORT COURSE IN

PHARMACEUTICAL

REGULATORY AFFAIRS

FOR EXECUTIVES

Registration formCertain student information is required to enable FPD to report on student achievements to the authorities as required. We ap

assistance in ensuring that our records are complete

Title Initials

Preferred Name

Surname

Qualification(s)

ID Number

Current Occupation

Name of facility you work in

Contact Numbers Work

Home

Fax

Cell

Postal Address

Area

Province

Physical Address

Area

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Professional Qualification

(Select one) General Practitioner

Auxiliary Nurse

In which ONE functional area do you spend most of your working day?

Sales/Marketing

Education

Workplace Demographics Select the ONE sector that best describes your main workplace

Select your main area of work

Level of care PHC

Race Black

Payment Method: Cheque

Credit card number

Last 3 digits at back of card

If payment is done by credit card budget account, mark period in months

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FPD BANKING DETAILS:

Nedbank Branch - Commercial, Pretoria

Account number: 1497 046 238 · Branch code: 14 97 45

PLEASE REMEMBER TO INDICATE THE PAYMENT REFERENCE AS BELOW AND FAX US THE DEPOSIT SLIP!

CANCELLATIONS:

FPD reserves the right to cancel or postpone a course. Applicants will and all fees will be refunded. Cancellations are accepted, IN WRITING and WITHOUT PENALTY, up to 14 days prior to date of commencement. Students cancelling less than 14 DAYS prior to date of commencement of the course will be liable for payment of 50% of the fees. NON-ARRIVALS will be liable for payment of the full fees. SUBSTITUTES will be accepted.

As registered student you will be included in our alumni mailing list for updates and/or information on new courses. Should y

Signature

Development (Pty) Ltd, Registration number 2000/002641/07

REGULATORY AFFAIRS

Registration form 2015Certain student information is required to enable FPD to report on student achievements to the authorities as required. We ap


Initials First Name

Male / Female

Professional Council nr (eg. HPCSA / SANC)

Code Number How did you hear about the course:

Code Number Word of mouth

Code Number Electronic

e-mail

Town

Country

Town

Country

General Practitioner Medical Specialist Professional Nurse

Other ___________________________________________________________

Research

Clinical

Select the ONE sector that best describes

NGO

Private sector

Select your main area of work Urban area Rural area

District: Province:

CHC Hospital

Asian Coloured

PAYMENT DETAIL

Credit Card Electronic Transfer

Expiry Date Master / Visa Card

If payment is done by credit card budget account, mark period in months 6 months

Card holder’s signature

number: 1497 046 238 · Branch code: 14 97 45

PLEASE REMEMBER TO INDICATE THE PAYMENT REFERENCE AS BELOW

EMAIL, POST OR FAX YOUR REGISTRATION FORM TOGETHER WITH YOUR PAYMENT TO:

CHANTAL ODENDAAL · Email: chantal

Tel: 012 816 9103/9254· Fax: 086 567 224375324, Lynnwood Ridge, 0040

Cheques must be made out to the Foundation for Professional Development

FPD reserves the right to cancel or postpone a course. Applicants will be informed and all fees will be refunded. Cancellations are accepted, IN WRITING and WITHOUT PENALTY, up to 14 days prior to date of commencement. Students cancelling less than 14 DAYS prior to date of commencement of the course will be

ARRIVALS will be liable for payment of

PAYMENT OF FEES:

Students are responsible for paying the full course fee before commencement thereof, or as per available payment options on a per course basis.

PAYMENT REFERENCE

SURNAME/

SUBSCRIPTION


2015 Certain student information is required to enable FPD to report on student achievements to the authorities as required. We appreciate your

How did you hear about the course:

Word of mouth FPD Workshop

Electronic DSTV Commercial

Code

Code

Enrolled Nurse

Other ___________________________________________________________

Management

Admin/Support

FBO (Faith based)

Public sector

Peri-Urban area

Province:

Other:

White

Electronic Transfer Bank Deposit

Master / Visa Card

12 months 18 months

EMAIL, POST OR FAX YOUR REGISTRATION FORM TOGETHER

· Email: [email protected]

086 567 2243· Postal address: PO Box

Cheques must be made out to the Foundation for Professional

Students are responsible for paying the full course fee before commencement thereof, or as per available payment options on a per

As registered student you will be included in our alumni mailing list for updates and/or information on new courses. Should you wish to subscribe, please sign.

Date:


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Short course in pharmaceutical regulatory

affairs for marketing departments INTRODUCTION

Marketing Departments and Regulatory Affairs Departments of a Pharmaceutical Company have interactive roles and responsibilities in terms of a host of legislation and statutory requirements. This course is designed to explain the requirements and create awareness around the various compliance and marketing inter-related activities.


Persons who work in the marketing department or who would like to gain insight into the field of compliant marketing, in the Pharmaceutical Industry.

COURSE OUTCOMES At the end of the course, the course delegates will:

• Be familiar with the roles and responsibilities, and operational and strategic functions of a Regulatory Affairs Department in a Pharmaceutical Company.

• Be familiar with the current statutory roles and responsibilities, functions, and operational and strategic activities of the responsible pharmacist in the Regulatory Affairs Department in a Pharmaceutical Company.

• Be familiar with the interaction between the Marketing Department and the Regulatory Affairs Department, the rules, the roles and responsibilities.

• Be familiar with the Regulators/Statutory Bodies etc including: - Overview of MCC and MRA structure and functions - Advertising Standards Authority of South Africa (ASASA) - SAPC, HPCSA and other practitioners' councils - Marketing Code Authority (MCA).

• Understand the structures of the administrative and decision-making arms of the MCC and Inspecorate/Law Enforcement where necessary.

• Have a concept of the Safety, Quality and Efficacy requirements of medicines, especially at interface of Health care Practitioners etc.

• Be aware of the MCC guidelines and those which impact Marketing’s roles and responsibilities.

• Be aware of the current medicine registration dossier fundamentals viz.: the ZA-CTD format, its modules, sections and granularity.

• Understand the registration process flow of the MCC

• Be aware of the Lifecycle management of a dossier

• Be familiarised with terminology and abbreviations used in the pharmaceutical regulatory environment.

• Know and understand the systems and work flows within Regulatory Affairs Department.

• Know the in-house guidance documents/SOPs pertaining to marketing- regulatory requirements.

• Understand the role and responsibility of the Pharmacovigilance Officer, including reporting requirements.

• Be aware of and know how to handle Complaints - product Quality, Safety, and Efficacy.

• Be aware of, know and apply the SA Marketing Code and MCA (Marketing Code Authority) (Section 18C of Act 101/1965 provides for establishment thereof) and its application; including perverse incentives.

• Be aware of and familiar with developing Marketing/ Advertising/Promotional Materials, source documents for references, and the approval and signing off by the Regulatory Affairs Department.

• The importance of the Product Labelling, viz PI, PIL and labels and outer - carton.

• Be aware of and familiar with the Marketing / Advertising / Promotional approvals process by Regulatory Affairs Department.

• Be aware of the MCC policy on Perverse Incentives.

• Be aware of Training requirements of Sales Representatives by the Regulatory Affairs Department.

• Be aware of and understand the Transparent Pricing System and Single Exit price.

• Pharmacoeconomics.


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CERTIFICATION

To qualify for the certificate of attendance for this short course, participants should fully attend the course. The practical scenarios/sessions must be completed to the satisfaction of the Facilitator.

COURSE FEE, DATE, VENUE AND PAYMENT R 6 023.76 (Inclusive of all VAT and taxes where applicable). 2 Day Course Attendees are responsible for paying the full course fee before commencement thereof. DATE VENUE FINAL REGISTRATION

DATE

14 – 15 April 2015 TBC 07 April 2015

06 – 07 October 2015 TBC 29 September 2015

REGISTRATION CHANTAL ODENDAAL / ILANA SWART Tel: 012 816 9103/9254 Fax: 086 567 2243 Email: [email protected] [email protected] Address: P.O. Box 75324, Lynnwood Ridge, 0040 Website: www.foundation.co.za


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SHORT COURSE IN

PHARMACEUTICAL

REGULATORY AFFAIRS

FOR MARKETING

DEPARTMENTS

Registration Certain student information is required to enable FPD to report on student achievements to the authorities as required. We ap


Title Initials

Preferred Name

Surname

Qualification(s)

ID Number

Current Occupation



Home

Fax

Cell

Postal Address

Area

Province

Physical Address

Area

Province



Auxiliary Nurse


Sales/Marketing

Education



Level of care PHC

Race Black


Credit card number








CANCELLATIONS:



Signature

Professional Development (Pty) Ltd, Registration number 2000/002641/07

REGULATORY AFFAIRS

Registration form 2015 Certain student information is required to enable FPD to report on student achievements to the authorities as required. We ap


Initials First Name

Male / Female





e-mail

Town

Country

Town

Country


Other ___________________________________________________________

Research

Clinical


NGO

Private sector


District: Province:

CHC Hospital

Asian Coloured

PAYMENT DETAIL








CHANTAL ODENDAAL · Email: chantalo





PAYMENT OF FEES:


PAYMENT REFERENCE

SURNAME/

SUBSCRIPTION


Certain student information is required to enable FPD to report on student achievements to the authorities as required. We appreciate your




Code

Code

Enrolled Nurse

Other ___________________________________________________________

Management

Admin/Support

FBO (Faith based)

Public sector

Peri-Urban area

Province:

Other:

White


Master / Visa Card

12 months 18 months







Date:


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affairs for regulatory affairs managers /

responsible pharmacists (RPs) INTRODUCTION

The operational activities, roles, responsibilities, the operational and strategic functions of a Medicine Regulatory Affairs Department in a Pharmaceutical Company requires the Regulatory Affairs Manager/Responsible Pharmacist (RP) to have a good understanding of the ever-changing medicines regulatory environment. The laws and regulations pertaining to the Pharmaceutical Industry, the statutory bodies, including the MCC, the SAPC and the Department of Health must be considered on a daily basis by the Regulatory Affairs Manager/Responsible Pharmacist (RP) to ensure the Safety, Quality and Efficacy of the medicines and health products available to the public.


Managers of Regulatory Affairs Departments within the Pharmaceutical Company setting, with or without manufacturing facilities, and, if the latter – which are either off-site inside South Africa or outside SA borders (Licensors/3

rd Party Contractors).

COURSE OUTCOMES At the end of the course, the course attendant will have insight and understanding into the operational and strategic roles and responsibilities of an RA Manager / Responsible Pharmacist, as follows:

• Have a good understanding and insight into the current operational activities, roles and responsibilities, and operational and strategic functions of a Regulatory Affairs Department in a Pharmaceutical Company, in a changing medicines regulatory, registration and control environment, and trends.

• Have a good understanding, knowledge and insight into the current statutory roles and responsibilities, functions, and operational and strategic activities of the Responsible Pharmacist in the Regulatory Affairs Department in a Pharmaceutical Company, in a changing regulatory environment.

• Have knowledge and understanding of the laws and regulations pertaining to the pharmaceutical industry, the establishment of statutory bodies, the MCC and the SAPC, and Law Enforcement for regulation, registration and control of medicines; and the concept of Safety, Quality, and Efficacy of Medicines.

• Have a good understanding of the Medicines Control Council; its structures and its administrative arm (MRA/Secretariat).

• Have an understanding of the Medicines and Related Substances Act and the Pharmacy Act.

• Understand the registration process flow and approval process.

• Know the different types of applications and the types of medicines.

• Understand the South African Medicine Registration dossier fundamentals, viz.: the ZA-CTD/eCTD, its modules and content.

• Know what MCC Guidelines are, and work through the different types of guidelines.

• Know and understand the Due Diligence assessment of a dossier, and ensure follow-up with licensor, 3rd parties etc.

• Product Labeling: PI, PIL, Labels.

• Clinical Amendments.

• Understand how to create and maintain electronic file structures, and how to prepare the Submission Ready Data in the ZA-CTD/eCTD format.

• Know how to manage MCC communication and correspondence.

• Know when not to proceed with a submission by identification of ‘Critical Data Shortcomings’.

• Understanding amendments and dossier maintenance, and the superseding of documentation – both electronically and hard copy documentation.

• Understand the Lifecycle of a dossier.

• Understand the issuing of the Registration Certificate, it's format and its Conditions of Registration.

• Understand Good Regulatory Practices and related Good Practices, as well as Best Practices.


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• Understand the use and application of terminology and abbreviations.

• Have an understanding of Risk Management

• Pharmacovigilance Systems – Reporting,

• Follow – up Record keeping.

• Post – marketing Surveillance and PSURs.

• Annual Product Review Reports and Product Quality Review.

• Transparent Pricing System (TPS) Single Exit Price (SEP).

• SA Marketing Code.

CERTIFICATION

To qualify for the certificate of attendance for this short course, participants should fully attend the course. The practical scenarios/sessions must be completed to the satisfaction of the Facilitator.


R 8 306.04 (Inclusive of all VAT and taxes where applicable). 3 Day Course Attendees/Trainees are responsible for paying the full course fee before commencement thereof. DATE VENUE FINAL REGISTRATION

DATE

21 - 23 July 2015 TBC 14 July 2015



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Short course in

Pharmaceutical

Regulatory affairs

For regulatory

Affairs managers /

Responsible pharmacists (RPs)

Registration formCertain student information is required to enable FPD to report on student achievements to the authorities as required. We appreciate your


Title Initials

Preferred Name

Surname

Qualification(s)

ID Number

Current Occupation



Home

Fax

Cell

Postal Address

Area

Province

Physical Address

Area

Province



Auxiliary Nurse


Sales/Marketing

Education



Level of care PHC

Race Black


Credit card number


If payment is done by credit card budget account, mark period in





PLEASE REMEMBER TO INDICATE THE PAYMENT REFERENCE AND FAX US THE DEPOSIT SLIP!

CANCELLATIONS:

FPD reserves the right to cancel or postpone a course. Applicants will be informed and all fees will be refunded. Cancellations are accepted, IN WRITING and WITHOUT PENALTY, up to 14 days prior to date of commencement. Students cancelling less than 14 DAYS prior to date of commencement of the course will be liable for payment of 50% of the fees. NON-ARRIVALS will be liable for payment of the full fees. SUBSTITUTES will be accepted.


Signature


pharmacists (RPs)

Registration form 2015required to enable FPD to report on student achievements to the authorities as required. We appreciate your


Initials First Name

Male / Female


Code Number How did you hear



e-mail

Town

Country

Town

Country


Other ___________________________________________________________

Research

Clinical


NGO

Private sector


District: Province:

CHC Hospital

Asian Coloured

PAYMENT DETAIL











FPD reserves the right to cancel or postpone a course. Applicants will be informed and all fees will be refunded. Cancellations are accepted, IN WRITING and

PENALTY, up to 14 days prior to date of commencement. Students cancelling less than 14 DAYS prior to date of commencement of the course will be


PAYMENT OF FEES:


PAYMENT REFERENCE

SURNAME/

SUBSCRIPTION

included in our alumni mailing list for updates and/or information on new courses. Should you wish to subscribe, please sign.

2015 required to enable FPD to report on student achievements to the authorities as required. We appreciate your




Code

Code

Enrolled Nurse

Other ___________________________________________________________

Management

Admin/Support

FBO (Faith based)

Public sector

Peri-Urban area

Province:

Other:

White


Master / Visa Card

12 months 18 months






included in our alumni mailing list for updates and/or information on new courses. Should you wish to subscribe, please sign.

Date:


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affairs for registration assistants INTRODUCTION To introduce and acquaint the trainee with the activities and functions of a Regulatory Affairs Department. To introduce and up-skill the trainee with the procedures and requirements of the medicine registration process and procedure. To train and up-skill the trainee with the knowledge and competence at appropriate learner level, with regulatory requirements for medicine registration applications for medicines of Medicines Control Council and Secretariat (MRA).

WHO SHOULD ENROLL / ATTEND Anyone interested in health product regulation, with at least a Grade 12 National Certificate (NQF 4).

COURSE OUTCOMES At the end of the course, the trainees will:

• Have insight into the functioning of the Medicines Control Council.

• Understand the structures of the administrative and decision-making arms of the MCC.

• Have a concept of the Safety, Quality and Efficacy requirements of Pharmaceutical products.

• Understand the registration process flow.

• Know when a substance is regarded as being a medicine.

• Be aware of the MCC guidelines.

• Know where to locate the MCC Guidelines, to know that they are dynamic, and how to supersede when updated.

• Understand the current medicine registration dossier fundamentals, viz: the ZA-CTD format, its Modules, Sections and Granularity.

• Know how to use the MCC Guideline 2.01 General Information, and 2.24 guidance for submission of the SA CTD/eCTD General and Module 1, and GL 2.21 SA Specification for eCTD Regional – Module 1, how this applies to Regulatory Affairs Assistants.

• Know how to create files structures electronically.

• Know how to prepare the submission copies – screening – checking, printing collating.

• Know how to file dossiers with the MCC and the appropriate MCC correspondence, e.g. electronically, hard copies, scanning.

• Know how to prepare multiple copies for post – screening submission.

• Understand dossier maintenance and superseding of documentation – both electronically and hard copy.

• Understand the lifecycle of a dossier.

• Understand communication with MCC – recommendation, faxes, post.

• Understand the issuing of the registration certificate and its conditions of registration.

• Understand the terminology and abbreviations used in the regulatory environment.

• Have undergone a practical session, which will be scenario based, with interaction between trainer and trainee.

• Have a basic understanding of the different types of applications.

CERTIFICATION To qualify for the certificate of completion for this short course, participants should fully attend the workshops as well as successfully complete any form of assessment.

COURSE FEE, DATE AND VENUE

R 12 870.60 (Inclusive of all VAT and taxes where applicable).. 5 Day Course DATE VENUE FINAL REGISTRATION

DATE

18 - 22 May 2015 TBC 11 May 2015 02 – 06 November 2015 TBC 30 October 2015

REGISTRATION



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Short course in

Pharmaceutical

Regulatory affairs

For registrations

Assistants

Registration formCertain student information is required to enable FPD to report on student achievements to the authorities as required. We appreciate your


Title Initials

Preferred Name

Surname

Qualification(s)

ID Number

Current Occupation



Home

Fax

Cell

Postal Address

Area

Province

Physical Address

Area

Province



Auxiliary Nurse


Sales/Marketing

Education



Level of care PHC

Race Black


Credit card number








CANCELLATIONS:

FPD reserves the right to cancel or postpone a course. and all fees will be refunded. Cancellations are accepted, IN WRITING and WITHOUT PENALTY, up to 14 days prior to date of commencement. Students cancelling less than 14 DAYS prior to date of commencement of the course will be liable for payment of 50% of the fees. NON-ARRIVALS will be liable for payment of the full fees. SUBSTITUTES will be accepted.


Signature


Registration form 2015required to enable FPD to report on student achievements to the authorities as required. We appreciate your


Initials First Name

Male / Female





e-mail

Town

Country

Town

Country


Other ___________________________________________________________

Research

Clinical


NGO

Private sector


District: Province:

CHC Hospital

Asian Coloured

PAYMENT DETAIL













PAYMENT OF FEES:

Students are responsible for paying the full course fee before commencement thereof, or as per available payment ocourse basis.

PAYMENT REFERENCE

SURNAME/

SUBSCRIPTION


2015 required to enable FPD to report on student achievements to the authorities as required. We appreciate your




Code

Code

Enrolled Nurse

Other ___________________________________________________________

Management

Admin/Support

FBO (Faith based)

Public sector

Peri-Urban area

Province:

Other:

White


Master / Visa Card

12 months 18 months







Date:


Back to Calendar




affairs for the senior regulatory affairs

pharmacist with ≥ 5 Years’ experience INTRODUCTION

The operational activities, roles and responsibilities together with the strategic functions of a Medicine Regulatory Affairs Department requires that the Senior Regulatory Affairs Pharmacist have a good understanding of the ever-changing regulatory environment.

WHO SHOULD ENROLL / ATTEND Regulatory Affairs Pharmacists with 5 or more than 5 years’ experience in the field.

COURSE OUTCOMES

At the end of the course, the course attendant will have insight and understanding of the Senior Registration Pharmacist’s roles and responsibilities, as follows:

• Have a good understanding and insight into the Regulatory Authority.

• Have an updated understanding of the Medicines and Related Substances Act and the Pharmacy Act.

• Have an updated knowledge and skill with regard to types of medicines, types of medicines, types of applications, the registration process flow and evaluation procedures.

• Have updated knowledge regarding the Guidelines, their purpose, and how to use them.

• Have updated knowledge and skill regarding application of the current registration ZA-CTD/eCTD dossier format, with its Modules, Sections, Granularity and the Content.

• Understand how to manage a Due Diligence checklist to ensure that dossiers are quality controlled and data requirements can be managed.

• Product Labelling: PI, PIL, Labels.

• Medical Safety Alerts, Safety and Clinical Amendments.

• Have updated knowledge and skill to manage the Creation and Maintenance of Electronic File Structures.

• Have updated knowledge and skill to review the presentation of Submission – Ready Documents in line with the ZA CTD / eCTD format and content.

• Have updated knowledge and skill to understand when not to proceed with a submission due to Critical Data Shortcomings’.

• Have updated knowledge and skill to review Amendments to the Dossier (post- screen, post-registration), Dossier Maintenance and Superseding of Documentation / Files.

• Have updated knowledge and skill to review the Life-cycle of a Medicine’s Registration Dossier , and to discuss problems that have been experienced.

• Have updated knowledge and skill to review the Medicine Registration Certificate Format and conditions of registration.

• Have updated knowledge and skill to review the principle of Good Regulatory Practices, and other related good Practices.

CERTIFICATION

To qualify for the certificate of completion for this short course, participants should fully attend the workshops as well as successfully complete any form of assessment.

COURSE FEE, DATE AND VENUE

R 8 303.76 (Inclusive of all VAT and taxes where applicable). 3 Days Course

DATE VENUE FINAL REGISTRATION DATE

09 – 11 June 2015 TBC 02 June 2015

REGISTRATION



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Short course in

Pharmaceutical

Regulatory affairs for

Senior regulatory affairs

Pharmacist with

≥ 5 Years’ experience

Registration Certain student information is required to enable FPD to report on student achievements to the authorities as required. We ap


Title Initials

Preferred Name

Surname

Qualification(s)

ID Number

Current Occupation



Home

Fax

Cell

Postal Address

Area

Province

Physical Address

Area

Province



Auxiliary Nurse


Sales/Marketing

Education



Level of care PHC

Race Black


Credit card number








CANCELLATIONS:



Signature


Regulatory affairs for

regulatory affairs

Registration form 2015Certain student information is required to enable FPD to report on student achievements to the authorities as required. We ap


First Name

Male / Female





e-mail

Town

Country

Town

Country


Other ___________________________________________________________

Research

Clinical


NGO

Private sector


District: Province:

CHC Hospital

Asian Coloured

PAYMENT DETAIL













PAYMENT OF FEES:


PAYMENT REFERENCE

SURNAME/

SUBSCRIPTION






Code

Code

Enrolled Nurse

Other ___________________________________________________________

Management

Admin/Support

FBO (Faith based)

Public sector

Peri-Urban area

Province:

Other:

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affairs for pharmacovigilance officer INTRODUCTION

Pharmacovigilance, is also known as Drug Safety. It is the pharmacological science relating to the collection, detection, assessment, monitoring, understanding, and prevention of adverse effects with pharmaceutical products, and includes the reporting thereof to the Regulatory Authority, i.e. the MCC and NADEMC. The Regulatory Affairs Department in a Pharmaceutical Company (the Applicant) should have a full-time qualified person(s) responsible for pharmacovigilance, both for pre- and post-marketing surveillance. Pharmacovigilance Officers should have experience and training in all aspects of pharmacovigilance and, if not a heath care professional, should have access to a medically qualified person. The roles and responsibilities of Pharmacovigilance Officer are outlined in the course outcomes below.


Pharmacists with suitable experience in regulatory affairs, and / or other suitably qualified persons who have 5 or more years experience in pharmaceutical regulatory affairs or similar. Depending on background, the minimum requirement is one of the following qualifications: Bachelor’s Degree in one of the following Health Sciences, viz: pharmacist, nurse, health practitioner, dentist, or one the other allied health practitioner categories.

COURSE OUTCOMES At the end of the course, the course attendant will have

insight and understanding into the operational and strategic

roles and responsibilities of a Pharmacovigilance Officer, as

follows:

• Have a good understanding and insight into the

current operational activities, roles and

responsibilities, and operational and strategic

functions of the Pharmacovigilance Officer within

the Regulatory Affairs Department in a

Pharmaceutical Company, in a changing medicines

regulatory, registration and control environment,

and trends.

• The Local and International PhV Guidelines.

• Introduction to Medicine Registration – why

products are registered, legislation awareness

• The Concept of Safety, Quality and Efficacy

• Regulators / Statutory Bodies etc.

- Overview of MCC and MRA structure and

functions, and Law Enforcement.

- Advertising Standards Authority of South Africa

- Consumer Protection Act

- SAPC, HPCSA and other practitioners’

councils.

• Registration Process Flow and Evaluation

Procedures.

• Types of Medicines; Types of Applications.

• Product Labelling PI, PIL, Labels and Medical

Safety Alerts, SR-PINS.

• Good Manufacturing Practice – good basic

understanding of roles and responsibilities tied up

with licensing.

• Systems and Work Flows within an RA Department

and MCC's.

• Pharmacovigilance Systems – Reporting of Adverse

Events/Adverse Drug Reaction/Serious Adverse

Events.

• Complaints Management.

• Marketing Code; Perverse Incentives.

• Availability and use of References / Source

Documentation.

• Importance of on – going Training for staff and self.

• Good Pharmacy Practice – High Level.

• Good Clinical Practice – High Level.

• Good Regulatory Practices.

• How and when to request access to specialists

within the company to assist in Evaluating Technical

Content.

• Post – Marketing Surveillance procedures and

reporting internally and externally.

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• Communication with the MCC and NADEMC and Pharmacovigilance Unit.

• Writing of PhV SOPs and updating thereof.

• Periodic Safety update Reports.

• Urgent Safety Restriction notice.

• Collaboration with Marketing Partners regarding

safety reporting and recalls.

CERTIFICATION

To qualify for the certificate of attendance for this short

course, participants should fully attend the course. The

practical scenarios/sessions must be completed to the

satisfaction of the Trainer.


R 8 306.04 (Inclusive of all VAT and taxes where applicable).

3 Day Course

Attendees/Trainees are responsible for paying the full course

fee before commencement thereof, or as per available

payment options.

DATE VENUE FINAL REGISTRATION DATE

03 – 05 March 2015 TBC 24 February 2015



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Short course in

Pharmaceutical

Regulatory affairs

For pharmacovigilance

Officer

Registration formCertain student information is required to enable FPD to report on student achievements to the authorities as required. We


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CANCELLATIONS:

FPD reserves the right to cancel or postpone a course. Applicants will be informed and all fees will be refunded. Cancellations are accepted, IN WRITING and WITHOUT PENALTY, up to 14 days prior to date of commencement. Students cancelling less than 14 DAYS prior to date of commencement of the course will be liable for payment of 50% of the fees. NON-ARRIVALS will be liable for payment of the full fees. SUBSTITUTES will be accepted.

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Registration form 2015Certain student information is required to enable FPD to report on student achievements to the authorities as required. We


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FPD reserves the right to cancel or postpone a course. Applicants will be informed and all fees will be refunded. Cancellations are accepted, IN WRITING and WITHOUT PENALTY, up to 14 days prior to date of commencement. Students

ss than 14 DAYS prior to date of commencement of the course will be ARRIVALS will be liable for payment of

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Students are responsible for paying the fullcommencement thereof, or as per available payment options on a per course basis.

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